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1.  The Potential Regimen of Target-Controlled Infusion of Propofol in Flexible Bronchoscopy Sedation: A Randomized Controlled Trial 
PLoS ONE  2013;8(4):e62744.
Target-controlled infusion (TCI) provides precise pharmacokinetic control of propofol concentration in the effect-site (Ce), eg. brain. This pilot study aims to evaluate the feasibility and optimal TCI regimen for flexible bronchoscopy (FB) sedation.
After alfentanil bolus, initial induction Ce of propofol was targeted at 2 μg/ml. Patients were randomized into three titration groups (i.e., by 0.5, 0.2 and 0.1 μg/ml, respectively) to maintain stable sedation levels and vital signs. Adverse events, frequency of adjustments, drug doses, and induction and recovery times were recorded.
The study was closed early due to significantly severe hypoxemia events (oxyhemoglobin saturation <70%) in the group titrated at 0.5 μg/ml. Forty-nine, 49 and 46 patients were enrolled into the 3 respective groups before study closure. The proportion of patients with hypoxemia events differed significantly between groups (67.3 vs. 46.9 vs. 41.3%, p = 0.027). Hypotension events, induction and recovery time and propofol doses were not different. The Ce of induction differed significantly between groups (2.4±0.5 vs. 2.1±0.4 vs. 2.1±0.3 μg/ml, p = 0.005) and the Ce of procedures was higher at 0.5 μg/ml titration (2.4±0.5 vs. 2.1±0.4 vs. 2.2±0.3 μg/ml, p = 0.006). The adjustment frequency tended to be higher for titration at 0.1 μg/ml but was not statistically significant (2 (0∼6) vs. 3 (0∼6) vs. 3 (0∼11)). Subgroup analysis revealed 14% of all patients required no further adjustment during the whole sedation. Comparing patients requiring at least one adjustment with those who did not, they were observed to have a shorter induction time (87.6±34.9 vs. 226.9±147.9 sec, p<0.001), a smaller induction dose and Ce (32.5±4.1 vs. 56.8±22.7 mg, p<0.001; 1.76±0.17 vs. 2.28 ±0.41, p<0.001, respectively), and less hypoxemia and hypotension (15.8 vs.56.9%, p = 0.001; 0 vs. 24.1%, p = 0.008, respectively).
Titration at 0.5 μg/ml is risky for FB sedation. A subgroup of patients required no more TCI adjustment with fewer complications. Further studies are warranted to determine the optimal regimen of TCI for FB sedation.
Trial Registration NCT01101477
PMCID: PMC3634750  PMID: 23638141
2.  Carbon dioxide accumulation during analgosedated colonoscopy: Comparison of propofol and midazolam 
AIM: To characterize the profiles of alveolar hypoventilation during colonoscopies performed under sedoanalgesia with a combination of alfentanil and either midazolam or propofol.
METHODS: Consecutive patients undergoing routine colonoscopy were randomly assigned to sedation with either propofol or midazolam in an open-labeled design using a titration scheme. All patients received 4 μg/kg per body weight alfentanil for analgesia and 3 L of supplemental oxygen. Oxygen saturation (SpO2) was measured by pulse oximetry (POX), and capnography (PcCO2) was continuously measured using a combined dedicated sensor at the ear lobe. Instances of apnea resulting in measures such as stimulation of the patient, a chin lift, a mask maneuver, or withholding of sedation were recorded. PcCO2 values (as a parameter of sedation-induced hypoventilation) were compared between groups at the following distinct time points: baseline, maximal rise, termination of the procedure and 5 min after termination of the procedure. The number of patients in both study groups who regained baseline PcCO2 values (± 1.5 mmHg) five minutes after the procedure was determined.
RESULTS: A total of 97 patients entered this study. The data from 14 patients were subsequently excluded for clinical procedure-related reasons or for technical problems. Therefore, 83 patients (mean age 62 ± 13 years) were successfully randomized to receive propofol (n = 42) or midazolam (n = 41) for sedation. Most of the patients were classified as American Society of Anesthesiologists (ASA) II [16 (38%) in the midazolam group and 15 (32%) in the propofol group] and ASA III [14 (33%) and 13 (32%) in the midazolam and propofol groups, respectively]. A mean dose of 5 (4-7) mg of IV midazolam and 131 (70-260) mg of IV propofol was used during the procedure in the corresponding study arms. The mean SpO2 at baseline (%) was 99 ± 1 for the midazolam group and 99 ± 1 for the propofol group. No cases of hypoxemia (SpO2 < 85%) or apnea were recorded. However, an increase in PcCO2 that indicated alveolar hypoventilation occurred in both groups after administration of the first drug and was not detected with pulse oximetry alone. The mean interval between the initiation of sedation and the time when the PcCO2 value increased to more than 2 mmHg was 2.8 ± 1.3 min for midazolam and 2.8 ± 1.1 min for propofol. The mean maximal rise was similar for both drugs: 8.6 ± 3.7 mmHg for midazolam and 7.4 ± 3.2 mmHg for propofol. Five minutes after the end of the procedure, the mean difference from the baseline values was significantly lower for the propofol treatment compared with midazolam (0.9 ± 3.0 mmHg vs 4.3 ± 3.7 mmHg, P = 0.0000169), and significantly more patients in the propofol group had regained their baseline value ± 1.5 mmHg (32 of 41 vs 12 of 42, P = 0.0004).
CONCLUSION: A significantly higher number of patients sedated with propofol had normalized PcCO2 values five minutes after sedation when compared with patients sedated with midazolam.
PMCID: PMC3471107  PMID: 23082055
Colonoscopy; Deep sedation; Propofol; Hypoventilation; Blood gas monitoring; Transcutaneous
3.  Arousal time from sedation during spinal anaesthesia for elective infraumbilical surgeries: Comparison between propofol and midazolam 
Indian Journal of Anaesthesia  2014;58(4):403-409.
Background and Aims:
Studies have already compared propofol and midazolam as sedatives during regional anaesthesia. A few studies have focused on recovery characteristics and very few have utilised both instrumental and clinical sedation monitoring for assessing recovery time. This study was designed primarily to compare arousal time from sedation using propofol with that of midazolam during spinal anaesthesia for infraumbilical surgeries, while depth of sedation was monitored continuously with bispectral index (BIS) monitor. The correlation between the BIS score and observer's assessment of awareness/sedation (OAA/S) score during recovery from sedation was also studied.
A total of 110 patients were randomly assigned to receive either propofol (Group P, n = 55) or midazolam (Group M, n = 55). Patients in the Group P received bolus of propofol (1 mg/kg), followed by infusion at 3 mg/kg/h; Group M received bolus of midazolam (0.05 mg/kg), followed by infusion at 0.06 mg/kg/h and titration until BIS score 70 was achieved and maintained between 65 and 70. OAA/S score was noted at BIS 70 and again at BIS 90 during recovery. The time to achieve OAA/S score 5 was noted. Spearman's correlation was calculated between the arousal time from sedation and the time taken to reach an OAA/S score of 5 in both the study groups.
Arousal time from sedation was found lower for Group P compared to Group M (7.54 ± 3.70 vs. 15.54 ± 6.93 min, respectively, P = 0.000). The time taken to reach OAA/S score 5 was also found to be lower for Group P than Group M (6.81 ± 2.54 min vs. 13.51 ± 6.24 min, respectively, P = 0.000).
A shorter arousal time from sedation during spinal anaesthesia can be achieved using propofol compared with midazolam, while depth of sedation was monitored with BIS monitor and OAA/S score. Both objective and clinical scoring correlate strongly during recovery from sedation.
PMCID: PMC4155284  PMID: 25197107
Bispectral index monitoring; midazolam; propofol; sedation; spinal anaesthesia
4.  A Randomized Evaluation of Bispectral Index-Augmented Sedation Assessment in Neurological Patients 
Neurocritical care  2009;11(1):20-27.
To assess whether monitoring sedation status using bispectral index (BIS) as an adjunct to clinical evaluation was associated with a reduction in the total amount of sedative drug used in a 12 h period.
Prospective randomized controlled clinical trial.
Tertiary care neurocritical care unit.
Sixty-seven mechanically ventilated adult patients receiving continuous intravenous sedation with propofol.
Sedation monitoring using clinical assessment with the Ramsay scale (Ramsay-alone group) or clinical assessment plus BIS monitoring (BIS-augmentation group). Subjects were randomized to Ramsay-alone (n = 35), or BIS-augmentation (n = 32). Nurses adjusted the dose of propofol to a Ramsay of 4, or a Ramsay of 4 and BIS between 60 and 70.
Measurements and Main Results
Patients in the BIS-augmentation group received significantly less propofol by volume (93.5 ml vs. 157.8 ml, respectively; P < .015), and had lower infusion rates (14.6 vs. 27.9 mcg/kg/min; P = .003). There is a lower risk of propofol infusion exceeding manufacturer’s recommended dosing guides in the BIS-augmentation group versus the Ramsay-alone group (0 vs. 23%, P = .0052). The BIS-augmentation group woke up much quicker than those in the Ramsay-alone group (1.2 vs. 7.5 min; P < .0001).
BIS-augmented sedation monitoring resulted in a marked reduction in the total dose of sedative used to achieve the same level of clinical sedation resulting in shortened time to wake up without any measurable adverse effects. Physiologic sedation assessment tools may provide a useful means of improving the care of sedated critically ill patients.
PMCID: PMC2706915  PMID: 19184556
Sedation assessment; Nursing care; Critical care; Neurofunction monitoring; Neurocritical care
5.  Monitoring sedation for bronchoscopy in mechanically ventilated patients by using the Ramsay sedation scale versus auditory-evoked potentials 
Appropriate sedation benefits patients by reducing the stress response, but it requires an appropriate method of assessment to adjust the dosage of sedatives. The aim of this study was to compare the difference in the sedation of mechanically ventilated patients undergoing flexible bronchoscopy (FB) monitored by auditory-evoked potentials (AEPs) or the Ramsay sedation scale (RSS).
In a prospective, randomized, controlled study, all patients who underwent FB with propofol sedation were monitored and their sedation adjusted. During FB, one group was monitored by AEP and another group was monitored by RSS. The propofol dosage was adjusted by the nursing staff during examination to maintain the Alaris AEP index (AAI) value between 25 and 40 in the AEP group and the RSS at 5 or 6 in the RSS group. Before FB and during FB, the AAI, heart rate (HR), and mean arterial pressure (MAP) were recorded every 5 min. The percentages of time at the sedation target and the propofol dosages were calculated.
Nineteen patients received AEP monitoring and 18 patients received RSS monitoring. The percentage of time at the sedation target during FB was significantly higher in the AEP monitoring group (51.3%; interquartile range [IQR], 47.0–63.5%) than in the RSS group (15.4%; IQR, 9.5–23.4%), (P < 0.001). During FB, the RSS group had a significantly higher AAI (P = 0.011), HR (P < 0.001), and MAP (P < 0.001) than the AEP group.
In mechanically ventilated patients undergoing FB, AEP monitoring resulted in less variation in AAI, HR, and MAP, and a higher percentage of time at the sedation target than RSS monitoring.
Trial registration NCT01448811.
PMCID: PMC3917902  PMID: 24499010
Auditory-evoked potential; Bronchoscopy; Critical care; Ramsay sedation score; Sedation
6.  Bispectral Index Monitoring during Anesthesiologist-Directed Propofol and Remifentanil Sedation for Endoscopic Submucosal Dissection: A Prospective Randomized Controlled Trial 
Yonsei Medical Journal  2014;55(5):1421-1429.
Endoscopic submucosal dissection (ESD) is a technically difficult and lengthy procedure requiring optimal depth of sedation. The bispectral index (BIS) monitor is a non-invasive tool that objectively evaluates the depth of sedation. The purpose of this prospective randomized controlled trial was to evaluate whether BIS guided sedation with propofol and remifentanil could reduce the number of patients requiring rescue propofol, and thus reduce the incidence of sedation- and/or procedure-related complications.
Materials and Methods
A total of 180 patients who underwent the ESD procedure for gastric adenoma or early gastric cancer were randomized to two groups. The control group (n=90) was monitored by the Modified Observer's Assessment of Alertness and Sedation scale and the BIS group (n=90) was monitored using BIS. The total doses of propofol and remifentanil, the need for rescue propofol, and the rates of complications were recorded.
The number of patients who needed rescue propofol during the procedure was significantly higher in the control group than the BIS group (47.8% vs. 30.0%, p=0.014). There were no significant differences in the incidence of sedation- and/or procedure-related complications.
BIS-guided propofol infusion combined with remifentanil reduced the number of patients requiring rescue propofol in ESD procedures. However, this finding did not lead to clinical benefits and thus BIS monitoring is of limited use during anesthesiologist-directed sedation.
PMCID: PMC4108833  PMID: 25048506
Bispectral index; endoscopic submucosal dissection; propofol; remifentanil
7.  Dexmedetomidine is effective for monitored anesthesia care in outpatients undergoing cataract surgery 
Korean Journal of Anesthesiology  2011;61(6):453-459.
Dexmedetomidine has a sedative analgesic property without respiratory depression. This study evaluated the efficacy of dexmedetomidine as an appropriate sedative drug for monitored anesthesia care (MAC) in outpatients undergoing cataract surgery on both eyes compared with combination of propofol and alfentanil.
Thirty-one eligible patients were randomly divided into two groups on the first operation day. Dexmedetomidine was administered in group D at 0.6 µg/kg/h, and propofol and alfentanil was infused concomitantly in group P at a rate of 2 mg/kg/h and 20 µg/kg/h, respectively. Sedation was titrated at Ramsay sedation score 3. Iowa satisfaction with anesthesia scale (ISAS) of the patients was evaluated postoperatively. Systolic blood pressure (SBP), heart rate (HR), respiration rate (RR), and peripheral oxygen saturation (SpO2) were recorded throughout the surgery. For the second operation, the group assignments were exchanged.
Postoperative ISAS was 50.3 (6.2) in group D and 42.7 (8.7) in group P, which was statistically significant (P < 0.001). SBP was significantly lower in group D compared with group P from the beginning of the operation. HR, RR, and SpO2 were comparable between the two groups. There were 8 cases (25.8%) of hypertension in group P, and 1 case (3.2%) in group D (P < 0.05). In contrast, 1 case (3.2%) of hypotension and 1 case (3.2%) of bradycardia occurred in group D.
Compared with the combined use of propofol and alfentanil, dexmedetomidine could be used appropriately for MAC in cataract surgery with better satisfaction from the patients and a more stable cardiovascular state.
PMCID: PMC3249565  PMID: 22220220
Cataract; Dexmedetomidine; Monitored anesthesia care; Propofol
8.  Deep sedation during gastrointestinal endoscopy: Propofol-fentanyl and midazolam-fentanyl regimens 
AIM: To compare deep sedation with propofol-fentanyl and midazolam-fentanyl regimens during upper gastrointestinal endoscopy.
METHODS: After obtaining approval of the research ethics committee and informed consent, 200 patients were evaluated and referred for upper gastrointestinal endoscopy. Patients were randomized to receive propofol-fentanyl or midazolam-fentanyl (n = 100/group). We assessed the level of sedation using the observer’s assessment of alertness/sedation (OAA/S) score and bispectral index (BIS). We evaluated patient and physician satisfaction, as well as the recovery time and complication rates. The statistical analysis was performed using SPSS statistical software and included the Mann-Whitney test, χ2 test, measurement of analysis of variance, and the κ statistic.
RESULTS: The times to induction of sedation, recovery, and discharge were shorter in the propofol-fentanyl group than the midazolam-fentanyl group. According to the OAA/S score, deep sedation events occurred in 25% of the propofol-fentanyl group and 11% of the midazolam-fentanyl group (P = 0.014). Additionally, deep sedation events occurred in 19% of the propofol-fentanyl group and 7% of the midazolam-fentanyl group according to the BIS scale (P = 0.039). There was good concordance between the OAA/S score and BIS for both groups (κ = 0.71 and κ = 0.63, respectively). Oxygen supplementation was required in 42% of the propofol-fentanyl group and 26% of the midazolam-fentanyl group (P = 0.025). The mean time to recovery was 28.82 and 44.13 min in the propofol-fentanyl and midazolam-fentanyl groups, respectively (P < 0.001). There were no severe complications in either group. Although patients were equally satisfied with both drug combinations, physicians were more satisfied with the propofol-fentanyl combination.
CONCLUSION: Deep sedation occurred with propofol-fentanyl and midazolam-fentanyl, but was more frequent in the former. Recovery was faster in the propofol-fentanyl group.
PMCID: PMC3683682  PMID: 23801836
Endoscopy; Deep sedation; Anesthetic administration; Anesthetic dose; Adverse effects
9.  Propofol versus Midazolam for Upper Gastrointestinal Endoscopy in Cirrhotic Patients: A Meta-Analysis of Randomized Controlled Trials 
PLoS ONE  2015;10(2):e0117585.
Sedation during gastrointestinal endoscopy is often achieved using propofol or midazolam in general population. However, impaired protein synthesis, altered drug metabolism, and compromised hepatic blood flow in patients with liver cirrhosis might affect the pharmacokinetics of sedatives, placing cirrhotic patients undergoing endoscopy at a greater risk of adverse events. The objective of this study was to assess comparative efficacies and safety of propofol and midazolam in cirrhotic patients undergoing endoscopy.
Randomized, controlled trials comparing propofol with midazolam in cirrhotic patients undergoing gastrointestinal endoscopy were selected. We performed the meta-analysis, using a random-effect model, the Review Manager, Version 5.2, statistical software package (Cochrane Collaboration, Oxford, UK) according to the PRISMA guidelines.
Five studies between 2003 and 2012, including 433 patients, were included. Propofol provided a shorter time to sedation (weight mean difference: -2.76 min, 95% confidence interval: -3.00 to -2.51) and a shorter recovery time (weight mean difference -6.17 min, 95% confidence interval: -6.81 to -5.54) than midazolam did. No intergroup difference in the incidence of hypotension, bradycardia, or hypoxemia was observed. Midazolam was associated with the deterioration of psychometric scores for a longer period than propofol.
This meta-analysis suggests that Propofol sedation for endoscopy provides more rapid sedation and recovery than midazolam does. The risk of sedation-related side effects for propofol does not differ significantly from that of midazolam. The efficacy of propofol in cirrhotic patients undergoing endoscopy is superior to those of midazolam.
PMCID: PMC4315567  PMID: 25646815
We sought to determine whether the combination of propofol and fentanyl results in lower propofol doses and fewer adverse cardiopulmonary events than propofol and placebo for lumbar puncture (LP) in children with acute hematologic malignancies.
Randomized, controlled, double blind, crossover study.
Pediatric Sedation Program
Children with acute leukemia or lymphoma receiving sedation for LP.
Each patient received two sedations in random order, one with propofol/placebo and one with propofol/fentanyl. The study investigator and patient/parent were blinded to placebo or fentanyl. Data collected included patient age and diagnosis, propofol dose and adverse events. Adverse events included oxygen saturation < 94%, airway obstruction, apnea, hypotension and bradycardia (< 5% mean for age). Logistic regression analysis was utilized to assess probability of adverse events and the Wilcoxon Signed Rank and McNemar’s tests were used for paired comparisons.
Measurements and Main Results
Twenty-two patients were enrolled. Fourteen patients were male and 8 were female. Each patient was studied twice for a total of 44 sedations. The median age was 5.0 years (range 2.2–17.2 years). All procedures were successfully completed. The median total dose of propofol was 5.05 mg/kg (range 2.4–10.2 mg/kg) for propofol/placebo versus 3.00 mg/kg (range 1.4–10.5 mg/kg) for propofol/fentanyl (p < 0.001). Twelve adverse events occurred in 11 of 22 patients (50.0%) propofol/placebo compared to 6 of 22 (18.2%) propofol/fentanyl (p= 0.02). The most common adverse event was hypotension.
The combination of propofol and fentanyl versus propofol alone for LP sedation in children with acute hematologic malignancies resulted in lower propofol doses and fewer adverse events.
PMCID: PMC3076743  PMID: 18838923
propofol; fentanyl; pediatric oncology; procedural sedation
11.  Dexmedetomidine compared with propofol for pediatric sedation during cerebral angiography 
Sedation of pediatric patients undergoing cerebral angiography is challenging. Although dexmedetomidine is used for sedation in various procedures, it has not been reported for pediatric patients undergoing cerebral angiography. This study compared the safety and efficacy of dexmedetomidine with that of propofol for cerebral angiography in pediatric patients.
Materials and Methods:
Sixty-two patients (6-15 years) scheduled for elective cerebral angiography were apportioned randomly and equally to receive either propofol or dexmedetomidine sedation. Patients in the propofol group received an initial bolus of intravenous propofol (1 mg/kg) and a maintenance infusion of 100 μg/kg/min. Patients in the dexmedetomidine group received an initial bolus of intravenous dexmedetomidine (1 μg/kg over 10 min) and a maintenance infusion of 1 μg/kg/h. An additional bolus of propofol 0.5 mg/kg or dexmedetomidine 0.25 μg/kg was repeated if needed. Procedure time, time to recovery and adverse events associated with sedation were recorded.
All cerebral angiographies were completed successfully under sedation with dexmedetomidine or propofol. Mean cerebral angiography time was 36 ± 10 min in the propofol group and 31 ± 7 min in the dexmedetomidine group (P = 0.047). The percentage of airway events and total adverse events were significantly higher in the propofol group (P < 0.05). Heart rate decreased in the dexmedetomidine group and mean arterial pressure decreased in the propofol group (P < 0.05, each).
Although cerebral angiography can be performed successfully under sedation with either propofol or dexmedetomidine, dexmedetomidine may be a better alternative because of fewer respiratory adverse events.
PMCID: PMC4155711  PMID: 25197298
Cerebral angiography; dexmedetomidine; pediatric sedation; propofol
12.  Bispectral index monitoring as an adjunct to nurse-administered combined sedation during endoscopic retrograde cholangiopancreatography 
AIM: To determine whether bispectral index (BIS) monitoring is useful for propofol administration for deep sedation during endoscopic retrograde cholangiopancreatography (ERCP).
METHODS: Fifty-nine consecutive patients with a variety of reasons for ERCP who underwent the procedure at least twice between 1 July 2010 and 30 November 2010. This was a randomized cross-over study, in which each patient underwent ERCP twice, once with BIS monitoring and once with control monitoring. Whether BIS monitoring was done during the first or second ERCP procedure was random. Patients were intermittently administered a mixed regimen including midazolam, pethidine, and propofol by trained nurses. The nurse used a routine practice to monitor sedation using the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale or the BIS monitoring. The total amount of midazolam and propofol used and serious side effects were compared between the BIS and control groups.
RESULTS: The mean total propofol dose administered was 53.1 ± 32.2 mg in the BIS group and 54.9 ± 30.8 mg in the control group (P = 0.673). The individual propofol dose received per minute during the ERCP procedure was 2.90 ± 1.83 mg/min in the BIS group and 3.44 ± 2.04 mg in the control group (P = 0.103). The median value of the MOAA/S score during the maintenance phase of sedation was comparable for the two groups. The mean BIS values throughout the procedure (from insertion to removal of the endoscope) were 76.5 ± 8.7 for all 59 patients in using the BIS monitor. No significant differences in the frequency of < 80% oxygen saturation, hypotension (< 80 mmHg), or bradycardia (< 50 beats/min) were observed between the two study groups. Four cases of poor cooperation occurred, in which the procedure should be stopped to add the propofol dose. After adding the propofol, the procedure could be conducted successfully (one case in the BIS group, three cases in the control group). The endoscopist rated patient sedation as excellent for all patients in both groups. All patients in both groups rated their level of satisfaction as high (no discomfort). During the post-procedural follow-up in the recovery area, no cases of clinically significant hypoxic episodes were recorded in either group. No other postoperative side effects related to sedation were observed in either group.
CONCLUSION: BIS monitoring trend to slighlty reduce the mean propofol dose. Nurse-administered propofol sedation under the supervision of a gastroenterologist may be considered an alternative under anesthesiologist.
PMCID: PMC3501778  PMID: 23180950
Conscious sedation; Bispectral index monitors; Pancreatic neoplasm; Endoscopic retrograde cholangiopancreatography
13.  Dexmedetomidine use in the ICU: Are we there yet? 
Critical Care  2013;17(3):320.
Expanded abstract
Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedeto midine for Long-Term Sedation Investigators: Dexmedetomidine vesus midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA 2012, 307:1151-1160.
Long-term sedation with midazolam or propofol in intensive care units (ICUs) has serious adverse effects. Dexmedetomidine, an alpha-2 agonist available for ICU sedation, may reduce the duration of mechanical ventilation and enhance patient comfort.
The objective was to determine the efficacy of dexmedetomidine versus midazolam or propofol (preferred usual care) in maintaining sedation, reducing duration of mechanical ventilation, and improving patients' interaction with nursing care.
Two phase 3 multicenter, randomized, double-blind trials were conducted.
The MIDEX (Midazolam vs. Dexmedetomidine) trial compared midazolam with dexmedetomidine in ICUs of 44 centers in nine European countries. The PRODEX (Propofol vs. Dexmedetomidine) trial compared propofol with dexmedetomidine in 31 centers in six European countries and two centers in Russia.
The subjects were adult ICU patients who were receiving mechanical ventilation and who needed light to moderate sedation for more than 24 hours.
After enrollment, 251 and 249 subjects were randomly assigned midazolam and dexmedetomidine, respectively, in the MIDEX trial, and 247 and 251 subjects were randomly assigned propofol and dexmedetomidine, respectively, in the PRODEX trial. Sedation with dexmedetomidine, midazolam, or propofol; daily sedation stops; and spontaneous breathing trials were employed.
For each trial, investigators tested whether dexmedetomidine was noninferior to control with respect to proportion of time at target sedation level (measured by Richmond Agitation Sedation Scale) and superior to control with respect to duration of mechanical ventilation. Secondary end points were the ability of the patient to communicate pain (measured by using a visual analogue scale [VAS]) and length of ICU stay. Time at target sedation was analyzed in per-protocol (midazolam, n = 233, versus dexmedetomidine, n = 227; propofol, n = 214, versus dexmedetomidine, n = 223) population.
Dexmedetomidine/midazolam ratio in time at target sedation was 1.07 (95% confidence interval (CI) 0.97 to 1.18), and dexmedetomidine/propofol ratio in time at target sedation was 1.00 (95% CI 0.92 to 1.08). Median duration of mechanical ventilation appeared shorter with dexmedetomidine (123 hours, interquartile range (IQR) 67 to 337) versus midazolam (164 hours, IQR 92 to 380; P = 0.03) but not with dexmedetomidine (97 hours, IQR 45 to 257) versus propofol (118 hours, IQR 48 to 327; P = 0.24). Patient interaction (measured by using VAS) was improved with dexmedetomidine (estimated score difference versus midazolam 19.7, 95% CI 15.2 to 24.2; P <0.001; and versus propofol 11.2, 95% CI 6.4 to 15.9; P <0.001). Lengths of ICU and hospital stays and mortality rates were similar. Dexmedetomidine versus midazolam patients had more hypotension (51/247 [20.6%] versus 29/250 [11.6%]; P = 0.007) and bradycardia (35/247 [14.2%] versus 13/250 [5.2%]; P <0.001).
Among ICU patients receiving prolonged mechanical ventilation, dexmedetomidine was not inferior to midazolam and propofol in maintaining light to moderate sedation. Dexmedetomidine reduced duration of mechanical ventilation compared with midazolam and improved the ability of patients to communicate pain compared with midazolam and propofol. Greater numbers of adverse effects were associated with dexmedetomidine.
PMCID: PMC3706806  PMID: 23731973
14.  The Influence of Injection Rate on the Hypnotic Effect of Propofol during Anesthesia: A Randomized Trial 
PLoS Clinical Trials  2006;1(3):e17.
Previous studies suggested that slow injection of propofol may increase the hypnotic effect during induction of anesthesia. The aim of the present study was therefore to investigate whether injection rate of propofol has an influence on its maximum effect.
Randomized, single-blind trial.
This study has been carried out in the operating rooms of a university hospital. An anesthesiologist and a resident performed the study with the aid of changing nursing staff.
We investigated 99 unpremedicated patients aged 18 to 60 years with American Society of Anesthesiologists (ASA) physical status 1–3.
Anesthesia was induced by intravenous injection of propofol (2 mg/kg). Propofol was manually injected in group 1 over a period of 5 s; in group 2 (120-s injection interval), and in group 3 (240-s injection interval), propofol was administered by an injection pump. After loss of consciousness, mask ventilation was performed with 100% oxygen. Bispectral index (BIS) was used to measure the hypnotic effect of propofol. After the decrease of BIS to the minimum value (i.e., maximum hypnotic effect) and the following increase of BIS to 60, the study period was finished and anesthesia was performed according to clinical criteria.
Outcome Measures:
We analyzed whether injection speed has an influence on the maximum hypnotic effect of a given dose of propofol (2 mg/kg).
BISmin marks the maximum electroencephalogram (EEG) effect of the propofol bolus as measured by the BIS. The lowest mean BISmin was measured in group 1 (28.7 ± 10.3). In group 2, BISmin was 33.0 (±13.9), and in group 3, BISmin was 36.4 (±11.0). There were no significant differences between group 2 and groups 1 or 3, but there were significant differences between groups 1 and 3. In group 1, BISmin was reached after 102.91 s (±44.20), in group 2 after 172.33 s (±29.76), and in group 3 after 274.21 s (±45.40). These differences were statistically significant for all comparisons. In summary, the lowest value for BISmin was achieved in the group with the fastest rate of propofol injection (group1, 5 s). The highest BISmin was obtained in the group with the slowest rate of injection (group 3, 240 s). The hemodynamic parameters were not significantly different among groups.
The hypnotic peak effect of propofol is lower with extremely slow injection (240 s versus 5 s). For clinically usual injection rates (5 s and 120 s), there was no significant difference in propofol peak effect.
Editorial Commentary
Background: Propofol is an injectable compound that is commonly used to bring about anesthesia in adults and in children aged more than three years. The rate at which propofol is injected is thought to affect the total dose of the drug that's needed to achieve loss of consciousness and lowered blood pressure during anesthesia. Previous trials have looked at the effect of different injection rates on anesthesia (time taken to lose consciousness, and degree of consciousness). In this trial of 99 patients scheduled for elective surgery, the researchers studied the effect of three different propofol injection rates. Patients were randomized to receive propofol injected over 5 s, 120 s, or 240 s. In each group the total dose of propofol (per kilogram of a patient's bodyweight) was the same. The main measure used to assess anesthetic effect was the bispectral index. This is a method of translating information from an electroencephalogram (graph showing electrical activity in the brain) into a standard measurement that reflects the patient's level of consciousness. The researchers also recorded time to loss of consciousness, i.e., when patients stopped responding to commands, and took blood pressure measurements.
What this trial shows: The researchers found that anesthetic effect, as measured using the bispectral index, was greatest in the patients who had received the fastest injections as compared with those who had received slower injections. However, the difference was only significant when comparing the fastest injection (5 seconds) with the slowest (240 seconds). In addition, the time taken to achieve anesthesia (as measured using the bispectral index), and time to loss of consciousness (as indicated by no response to commands), were lowest in patients who had the fastest injections; these differences were also significant. The researchers did not find an effect of the different injection rates on maximum and minimum blood pressure during the trial.
Strengths and limitations: The trial recruited enough patients to properly assess whether patients receiving different injection rates would have different responses to anesthesia. A limitation, acknowledged by the authors, is that the bispectral index uses a commercial computer program to interpret electroencephalograms and to produce a number value for anesthetic effect. Some evidence suggests that the output of the computer program may not correlate precisely with level of consciousness, and as the algorithm is not public, any irregularities in the way it works cannot be discovered by researchers outside the company. It is also of note that the slowest injection rate used by the researchers, 240 seconds, is not normally used in clinical practice.
Contribution to the evidence: The results of this study support those from a few other small randomized trials that faster injections of propofol achieve a larger anesthetic effect, and more quickly. However, the effect of injection rate on blood pressure is less clear; this study does not show any differences in the effect of injection rate on blood pressure, but other randomized trials have found an association.
PMCID: PMC1523225  PMID: 16878179
15.  Clinical vs. bispectral index-guided propofol induction of anesthesia: A comparative study 
Saudi Journal of Anaesthesia  2013;7(1):75-79.
Clinically optimized focusing of drug administration to specific need of patient with bispectral index (BIS) monitoring results in reduced dose and faster recovery of consciousness. This study was planned with an aim to study and compare the conventional clinical end point or BIS on the requirement of dosage of propofol, hemodynamic effects, and BIS alterations following propofol induction.
70 patients, ASA I and II, 20-60 years undergoing elective surgical procedure under general anesthesia with endotracheal intubation were selected and divided into two groups. Group A received (inj.) fentanyl (2 μg/kg), followed 3 min later by inj. propofol at the rate of 30 mg/kg/hr infusion till the loss of response to verbal command while group B received inj. fentanyl (2 μg/kg), followed 3 min later by inj. propofol at the rate of 30 mg/kg/hr infusion. The end point of hypnosis was when the BIS value was sustained for 1 min at 48±2. The patients were intubated. Total induction dose of propofol was noted in each group. The value of BIS and hemodynamic parameters (heart rate, systolic/diastolic blood pressure) were noted at the time of loss of consciousness, at the time of intubation, and 1 min after intubation, thereafter every minute for first 10 min and thereafter every 10 min till end of surgery. Any involuntary muscle activity such as jerky movements, dystonic posturing, and opisthotonos were also recorded.
The mean dose of propofol used in groups A and B were 1.85±0.48 mg/kg and 1.79±0.41 mg/kg, respectively. The dosage used in group B were less but not clinically significant (P=0.575). On comparing the dosage of propofol in males among the groups there was a significantly lower dosage of propofol required in group B (2.06±0.45 mg/kg and 1.83±0.32 mg/kg, respectively, P=0.016). This decrease however was not seen in female patients dosage being 1.65±0.44 mg/kg and 1.75±0.49 mg/kg, respectively (P=0.372). The hemodynamic variables including heart rate, systolic/diastolic blood pressure and BIS were comparable within the group at induction, post-induction, and intubation. However, there was a significant increase in all the parameters at postintubation readings (P<0.001).
No significant difference in the induction dose of propofol was observed when assessed clinically (loss of verbal response) or by BIS monitoring. Traditional teaching to titrate the dose of propofol and depth of anesthesia during intubation by loss of verbal response is as good as BIS value monitoring.
PMCID: PMC3657931  PMID: 23717237
Anesthesia management; bispectral index; dosage; propofol
16.  Midazolam and propofol used alone or sequentially for long-term sedation in critically ill, mechanically ventilated patients: a prospective, randomized study 
Critical Care  2014;18(3):R122.
Midazolam and propofol used alone for long-term sedation are associated with adverse effects. Sequential use may reduce the adverse effects, and lead to faster recovery, earlier extubation and lower costs. This study evaluates the effects, safety, and cost of midazolam, propofol, and their sequential use for long-term sedation in critically ill mechanically ventilated patients.
A total of 135 patients who required mechanical ventilation for >3 days were randomly assigned to receive midazolam (group M), propofol (group P), or sequential use of both (group M-P). In group M-P, midazolam was switched to propofol until the patients passed the spontaneous breathing trial (SBT) safety screen. The primary endpoints included recovery time, extubation time and mechanical ventilation time. The secondary endpoints were pharmaceutical cost, total cost of ICU stay, and recollection to mechanical ventilation-related events.
The incidence of agitation following cessation of sedation in group M-P was lower than group M (19.4% versus 48.7%, P = 0.01). The mean percentage of adequate sedation and duration of sedation were similar in the three groups. The recovery time, extubation time and mechanical ventilation time of group M were 58.0 (interquartile range (IQR), 39.0) hours, 45.0 (IQR, 24.5) hours, and 192.0 (IQR, 124.0) hours, respectively; these were significantly longer than the other groups, while they were similar between the other two groups. In the treatment-received analysis, ICU duration was longer in group M than group M-P (P = 0.016). Using an intention-to-treat analysis and a treatment-received analysis, respectively, the pharmaceutical cost of group M-P was lower than group P (P <0.01) and its ICU cost was lower than group M (P <0.01; P = 0.015). The proportion of group M-P with unbearable memory of the uncomfortable events was lower than in group M (11.7% versus 25.0%, P <0.01), while the proportion with no memory was similar (P >0.05). The incidence of hypotension in group M-P was lower than group (P = 0.01).
Sequential use of midazolam and propofol was a safe and effective sedation protocol, with higher clinical effectiveness and better cost-benefit ratio than midazolam or propofol used alone, for long-term sedation of critically ill mechanically ventilated patients.
Trial registration
Current Controlled Trials ISRCTN01173443. Registered 25 February 2014.
PMCID: PMC4095601  PMID: 24935517
17.  Comparison between the recovery time of alfentanil and fentanyl in balanced propofol sedation for gastrointestinal and colonoscopy: a prospective, randomized study 
BMC Gastroenterology  2012;12:164.
There is increasing interest in balanced propofol sedation (BPS) titrated to moderate sedation (conscious sedation) for endoscopic procedures. However, few controlled studies on BPS targeted to deep sedation for diagnostic endoscopy were found. Alfentanil, a rapid and short-acting synthetic analog of fentanyl, appears to offer clinically significant advantages over fentanyl during outpatient anesthesia.
It is reasonable to hypothesize that low dose of alfentanil used in BPS might also result in more rapid recovery as compared with fentanyl.
A prospective, randomized and double-blinded clinical trial of alfentanil, midazolam and propofol versus fentanyl, midazolam and propofol in 272 outpatients undergoing diagnostic esophagogastroduodenal endoscopy (EGD) and colonoscopy for health examination were enrolled. Randomization was achieved by using the computer-generated random sequence. Each combination regimen was titrated to deep sedation. The recovery time, patient satisfaction, safety and the efficacy and cost benefit between groups were compared.
260 participants were analyzed, 129 in alfentanil group and 131 in fentanyl group. There is no significant difference in sex, age, body weight, BMI and ASA distribution between two groups. Also, there is no significant difference in recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between two groups. Though deep sedation was targeted, all cardiopulmonary complications were minor and transient (10.8%, 28/260). No serious adverse events including the use of flumazenil, assisted ventilation, permanent injury or death, and temporary or permanent interruption of procedure were found in both groups. However, fentanyl is New Taiwan Dollar (NT$) 103 (approximate US$ 4) cheaper than alfentanil, leading to a significant difference in total cost between two groups.
This randomized, double-blinded clinical trial showed that there is no significant difference in the recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between the two most common sedation regimens for EGD and colonoscopy in our hospital. However, fentanyl is NT$103 (US$ 4) cheaper than alfentanil in each case.
Trial registration
Institutional Review Board of Buddhist Tzu Chi General Hospital (IRB097-18) and Chinese Clinical Trial Registry (ChiCTR-TRC-12002575)
PMCID: PMC3607964  PMID: 23170921
Balanced propofol sedation; Alfentanil; Fentanyl; Deep sedation; Diagnostic endoscopy; Cost benefit
18.  Comparison of Propofol-Remifentanil Versus Propofol-Ketamine Deep Sedation for Third Molar Surgery 
Anesthesia Progress  2012;59(3):107-117.
This study aimed to compare continuous intravenous infusion combinations of propofol-remifentanil and propofol-ketamine for deep sedation for surgical extraction of all 4 third molars. In a prospective, randomized, double-blinded controlled study, participants received 1 of 2 sedative combinations for deep sedation for the surgery. Both groups initially received midazolam 0.03 mg/kg for baseline sedation. The control group then received a combination of propofol-remifentanil in a ratio of 10 mg propofol to 5 μg of remifentanil per milliliter, and the experimental group received a combination of propofol-ketamine in a ratio of 10 mg of propofol to 2.5 mg of ketamine per milliliter; both were given at an initial propofol infusion rate of 100 μg/kg/min. Each group received an induction loading bolus of 500 μg/kg of the assigned propofol combination along with the appropriate continuous infusion combination . Measured outcomes included emergence and recovery times, various sedation parameters, hemodynamic and respiratory stability, patient and surgeon satisfaction, postoperative course, and associated drug costs. Thirty-seven participants were enrolled in the study. Both groups demonstrated similar sedation parameters and hemodynamic and respiratory stability; however, the ketamine group had prolonged emergence (13.6 ± 6.6 versus 7.1 ± 3.7 minutes, P = .0009) and recovery (42.9 ± 18.7 versus 24.7 ± 7.6 minutes, P = .0004) times. The prolonged recovery profile of continuously infused propofol-ketamine may limit its effectiveness as an alternative to propofol-remifentanil for deep sedation for third molar extraction and perhaps other short oral surgical procedures, especially in the ambulatory dental setting.
PMCID: PMC3468288  PMID: 23050750
Propofol; Ketamine; Remifentanil; Deep sedation; TIVA
19.  Evaluation of Pharyngeal Function between No Bolus and Bolus Propofol Induced Sedation for Advanced Upper Endoscopy 
This study aimed to assess pharyngeal function between no bolus and bolus propofol induced sedation during gastric endoscopic submucosal dissection. A retrospective study was conducted involving consecutive gastric cancer patients. Patients in the no bolus group received a 3 mg/kg/h maintenance dose of propofol after the initiation of sedation without bolus injection. All patients in the bolus group received the same maintenance dose of propofol with bolus 0.5 mg/kg propofol injection. Pharyngeal functions were evaluated endoscopically for the first 5 min following the initial administration of propofol. Fourteen patients received no bolus propofol induction and 13 received bolus propofol induction. Motionless vocal cords were observed in 2 patients (14%) in the no bolus group and 3 (23%) in the bolus group. Trachea cartilage was not observed in the no bolus group but was apparent in 6 patients (46%) in the bolus group (P < 0.01). Scope stimulated pharyngeal reflex was observed in 11 patients (79%) in the no bolus group and in 3 (23%) in the bolus group (P < 0.01). Propofol induced sedation without bolus administration preserves pharyngeal function and may constitute a safer sedation method than with bolus.
PMCID: PMC3958785  PMID: 24723747
20.  Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study 
BMC Anesthesiology  2012;12:20.
ERCP practically requires moderate to deep sedation controlled by a combination of benzodiazepine and opiod. Propofol as a sole agent may cause oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and we hypothesized that it might decrease the risk of oversedation. We prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP.
ERCP patients were randomized into 2 groups; the cocktail group (n = 103) and the controls (n = 102). For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were administered in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation.
In the cocktail group, the average administration rate of propofol was 6.2 mg/kg/hr. In the control group; average weight base dosage of meperidine and midazolam were 1.03 mg/kg and 0.12 mg/kg, respectively. Recovery times and patients’ satisfaction scores in the cocktail and control groups were 9.67 minutes and 12.89 minutes (P = 0.045), 93.1and 87.6 (P <0.001), respectively. Desaturation rates in the cocktail and conventional groups were 58.3% and 31.4% (P <0.001), respectively. All desaturations were corrected with temporary oxygen supplementation without the need for scope removal.
Cocktail sedation containing propofol provides faster recovery time and better patients’ satisfaction for patients undergoing ERCP. However, mild degree of desaturation may still develop.
Trial registration, NCT01540084
PMCID: PMC3434082  PMID: 22873637
Cocktail sedation containing propofol; Meperidine; Midazolam; ERCP
21.  Comparison of recovery characteristics, postoperative nausea and vomiting, and gastrointestinal motility with total intravenous anesthesia with propofol versus inhalation anesthesia with desflurane for laparoscopic cholecystectomy: A randomized controlled study 
Background:Clinical effects, recovery characteristics, and costs of total intravenous anesthesia with different inhalational anesthetics have been investigated and compared; however, there are no reported clinical studies focusing on the effects of anesthesia with propofol and desflurane in patients undergoing laparoscopic cholecystectomy.
Objective: The aim of this study was to determine the effects of total intravenous anesthesia with propofol and alfentanil compared with those of desflurane and alfentanil on recovery characteristics, postoperative nausea and vomiting (PONV), duration of hospitalization, and gastrointestinal motility.
Methods: Patients classified as American Society of Anesthesiologists physical status I or II undergoing elective laparoscopic cholecystectomy due to benign gallbladder disease were enrolled in the study. Patients were randomly assigned at a 1:1 ratio to receive total intravenous anesthesia with propofol (2–2.5 mg/kg) and alfentanil (20 μg/kg) or desflurane (4%–6%) and alfentanil (20 μg/kg). Perioperative management during premedication, intraoperative analgesia, relaxation, ventilation, and postoperative analgesia were carried out identically in the 2 groups. Extubation time, recovery time, PONV, postoperative antiemetic requirement, time to gastrointestinal motility and flatus, duration of hospitalization, and adverse effects were recorded. Postoperative pain was assessed using a visual analogue scale.
Results: Sixty-eight patients were assessed for inclusion in the study; 5 were excluded because they chose open surgery and 3 did not complete the study because they left the hospital. Sixty patients (33 women, 27 men) completed the study. Recovery time was significantly shorter in the propofol group (n = 30) compared with the desflurane group (n = 30) (8.0 [0.77] vs 9.2 [0.66] min, respectively; P < 0.005). Fifteen patients (50.0%) in the propofol group and 20 patients (66.7%) in the desflurane group experienced nausea during the first 24 hours after surgery. The difference was not considered significant. In the propofol group, significantly fewer patients had vomiting episodes compared with those in the desflurane group (2 [6.7%] vs 16 [53.3%]; P < 0.005). Significantly fewer patients in the propofol group required analgesic medication in the first 24 hours after surgery compared with those in the desflurane group (10 [33.3%] vs 15 [50.0%]; P < 0.005). Patients in the propofol group experienced bowel movements in a significantly shorter period of time compared with patients in the desflurane group (8.30 [1.67] vs 9.76 [1.88] hours; P = 0.02). The mean time to flatus occurred significantly sooner after surgery in the propofol group than in the desflurane group (8.70 [1.79] vs 9.46 [2.09] hours; P = 0.01). The duration of hospitalization after surgery was significantly shorter in the propofol group than in the desflurane group (40.60 [3.49] vs 43.60 [3.56] hours; P = 0.03).
Conclusion: Total intravenous anesthesia with propofol and alfentanil was associated with a significantly reduced rate of PONV and analgesic consumption, shortened recovery time and duration of hospitalization, accelerated onset of bowel movements, and increased patient satisfaction compared with desflurane and alfentanil in these patients undergoing laparoscopic surgery who completed the study.
PMCID: PMC3967343  PMID: 24683221
total intravenous anesthesia; propofol; desflurane; alfentanil; laparoscopic cholecystectomy
22.  Comparison of Midazolam and Propofol for BIS-Guided Sedation During Regional Anaesthesia 
Indian Journal of Anaesthesia  2009;53(6):662-666.
Regional anaesthesia has become an important anaesthetic technique. Effective sedation is an essential for regional techniques too. This study compares midazolam and propofol in terms of onset & recovery from sedation, dosage and side effects of both the drugs using Bispectral Index monitoring. Ninety eight patients were randomly divided into two groups,one group recieved midazolam infusion while the other recieved propofol infusion until BIS reached 75. We observed Time to reach desired sedation, HR, MABP, time for recovery, dose to reach sedation and for maintenance of sedation and side effects if any. The time to reach required sedation was 11 min in Midazolam group(Group I) while it was 6 min in Propofol group(Group II) (p=0.0). Fall in MABP was greater with propofol. Recovery in with midazolam was slower than with propofol (18.6 ± 6.5 vs 10.10±3.65 min) (p=0.00). We concluded that both midazolam and propofol are effective sedatives, but onset and offset was quicker with propofol, while midazolam was more cardiostable.
PMCID: PMC2900075  PMID: 20640093
Propofol; Midazolam; Sedation; BIS
23.  Patient-controlled sedation with propofol/remifentanil versus propofol/alfentanil for patients undergoing outpatient colonoscopy, a randomized, controlled double-blind study 
Saudi Journal of Anaesthesia  2014;8(Suppl 1):S36-S40.
Many techniques are used for sedation of colonoscopies. Patient-controlled sedation (PCS) is utilizing many drugs or drug combinations.
The aim of this study is to compare the safety and feasibility of propofol/remifentanil versus propofol/alfentanil given to sedate patients undergoing outpatient colonoscopies through a patient-controlled technique.
Settings and Design:
Controlled randomized and double-blind study.
Materials and Methods:
A total of 80 patients were randomly divided into two groups; PA group received a combination of propofol/alfentanil and PR group received propofol/remifentanil combination. Patients were monitored for heart rate (HR), blood pressure (BP), oxygen saturation, and Ramsay sedation scale (RSS). Times of the following events were recorded; initiation of sedation, insertion and removal of the colonoscope, recovery and discharge. Five intervals were calculated; time to sedation, procedure time, postprocedure time, procedure room time, and postanesthesia care unit (PACU) time. Endoscopist and patient satisfaction scores were obtained.
Statistical Analysis Used:
Unpaired Student's t-test was used to compare between the two groups. Paired Student's t-test was used to compare baseline readings with readings after 30 min of sedation in the same group when needed.
Both groups showed slowing of the HR and decrease in mean arterial BP. HR and mean arterial BP were significantly lower 5 and 10 min after initiation of sedation in PR group when compared with PA group. Both HR and mean arterial BP returned to presedation readings 30 min after initiation of sedation in PR group but not in PA group. No differences between the two groups concerning oxygen saturation, RSS, endoscopist and patient satisfaction scores. Postprocedure and PACU times were significantly prolonged in PA group.
PCS with either remifentanil/propofol or alfentanil/propofol for patients undergoing outpatient colonoscopy is safe and feasible. Remifentanil/proofol has more beneficial advantages in this setting secondary to its more rapid clearance.
PMCID: PMC4268525  PMID: 25538518
Alfentanil; colonoscopy; patient-controlled sedation; remifentanil
24.  Safety and Efficacy of Deep Sedation with Propofol Alone or Combined with Midazolam Administrated by Nonanesthesiologist for Gastric Endoscopic Submucosal Dissection 
Gut and Liver  2012;6(4):464-470.
Endoscopic submucosal dissection (ESD) is accepted as a treatment for gastric neoplasms and usually requires deep sedation. The aim of this study was to evaluate the safety and efficacy profiles of deep sedation induced by continuous propofol infusion with or without midazolam during ESD.
A total of 135 patients scheduled for ESDs between December 2008 and June 2010 were included in this prospective study and were randomly assigned to one of two groups: the propofol group or the combination group (propofol plus midazolam).
The propofol group reported only one case of severe hypoxemia with no need of mask ventilation or intubation. Additionally, 18 cases of mild hypotension were observed in the propofol group, and 11 cases were observed in the combination group. The combination group had a lower mean total propofol dose (378 mg vs 466 mg, p<0.012), a longer mean recovery time (10.5 minutes vs 7.9 minutes, p=0.027), and a lower frequency of overall adverse events (32.8% vs 17.6%, p=0.042).
Deep sedation induced by continuous propofol infusion was shown to be safe during ESD. The combination of continuous propofol infusion and intermittent midazolam injection can decrease the total dose and infusion rate of propofol and the overall occurrence of adverse events.
PMCID: PMC3493727  PMID: 23170151
Deep sedation; Propofol; Midazolam; Endoscopy; Gastrointestinal
25.  Assessment of the effects of ketamine-fentanyl combination versus propofol-remifentanil combination for sedation during endoscopic retrograde cholangiopancreatography 
Endoscopic retrograde cholangiopancreatography (ERCP) as a diagnostic and treatment procedure is used in most biliary tract and pancreatic. Either sedation or general anesthesia could be considered for this procedure. Combining a sedative with an opioid agent can provide effective moderate sedation. This study compared the impact of ketamine-fentanyl (KF) versus propofol-remifentanil (PR) on sedation scale in patients undergoing ERCP.
Materials and Methods:
As a double-blinded randomized clinical trial, 80 patients selected by convenient sampling, allocated randomly into two groups. KF group received ketamine 0.5 mg/kg body weight intravenously over 60 s and then fentanyl 1 mcg/kg body weight intravenously. PR group received propofol l mg/kg body weight intravenously over 60 s and then remifentanil 0.05 mcg/kg body weight/min intravenously. Intravenous (IV) infusion of propofol was maintained by 50 mcg/kg body weight/min throughout ERCP. Ramsay Sedation Score, vital signs, oxygen saturation (SpO2), recovery score (modified Aldrete score) and visual analog scales of pain intensity, and endoscopist's satisfaction were considered as measured outcomes. All analysis were analyzed by SPSS Statistics version 22 and using t-test, Chi-square and repeated measured ANOVA and Mann-Whitney tests for data analysis.
Respiratory rate and SpO2 level during the time intervals were lower in PR group (P < 0.001). Sedation score at intervals was not significantly different (P = 0.07). The frequency of apnea in PR group was significantly higher than the KF group (P = 0.003). The percentage of need to supplemental oxygen in PR group was 35.1% that was also significantly higher than 8.8% in the KF group (P = 0.008), but the dosage frequency was significantly higher in KF group (P < 0.001). The KF and PR groups average length of stay in the recovery room were 50.71 standard deviation (SD = 9.99) and 42.57 (SD = 11.99) minutes, respectively, indicating a significant difference (P = 0.003). The mean severity of nausea in KF and PR groups was, respectively, 2.74 confidence interval (CI = 1.68-3.81) and 0.43 (CI = 0.11-0.75), that was significantly higher in KF group (P < 0.001). The average score of surgeon satisfaction in both KF and PR groups were 7.69 (CI = 7.16-8.21) and 8.65 (CI = 8.25-9.05), respectively, which was higher in KF group (P = 0.004), but the average level of patients satisfaction in KF group was 8.86 (CI = 8.53-9.19) and in PR group was 8.95 (CI - 8.54-9.35) that were not significantly different (P = 0.074).
There is no statistically significant difference between KF and PR combinations in sedation score, but PR combination provides better pain control, with less nausea and shorter recovery time while causing more respiratory side effects, that is, apnea and need to oxygen.
PMCID: PMC4268195  PMID: 25535501
Endoscopic retrograde cholangiopancreatography; fentanyl; ketamine; propofol; remifentanil

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