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1.  Age-dependent safety analysis of propofol-based deep sedation for ERCP and EUS procedures at an endoscopy training center in a developing country 
Introduction
Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasonography (EUS) procedures in elderly patients are on the rise, and they play an important role in the diagnosis and management of various gastrointestinal diseases. The use of deep sedation in these patients has been established as a safe and effective technique in Western countries; however, it is uncertain if the situation holds true among Asians. The present study aimed to evaluate the age-dependent safety analysis and clinical efficacy of propofol-based deep sedation (PBDS) for ERCP and EUS procedures in adult patients at a World Gastroenterology Organization (WGO) Endoscopy Training Center in Thailand.
Methods
We undertook a retrospective review of anesthesia or sedation service records of patients who underwent ERCP and EUS procedures. All procedures were performed by staff endoscopists, and all sedations were administered by anesthesia personnel in the endoscopy room.
Results
PBDS was provided for 491 ERCP and EUS procedures. Of these, 252 patients (mean age, 45.1 + 11.1 years, range 17–65 years) were in the <65 age group, 209 patients (mean age, 71.7 + 4.3 years, range 65–80 years) were in the 65–80 year-old group, and 30 patients (mean age, 84.6 + 4.2 years, range 81–97 years) were in the >80 age group. Common indications for the procedures were pancreatic tumor, cholelithiasis, and gastric tumor. Fentanyl, propofol, and midazolam were the most common sedative drugs used in all three groups. The mean doses of propofol and midazolam in the very old patients were relatively lower than in the other groups. The combination of propofol, midazolam, and fentanyl, as well as propofol and fentanyl, were frequently used in all patients. Sedation-related adverse events and procedure-related complications were not statistically significantly different among the three groups. Hypotension was the most common complication.
Conclusion
In the setting of the WGO Endoscopy Training Center in a developing country, PBDS for ERCP and EUS procedures in elderly patients by trained anesthesia personnel with appropriate monitoring is relatively safe and effective. Although adverse cardiovascular events, including hypotension, in this aged group is common, all adverse events were usually transient, mild, and easily treated, with no sequelae.
doi:10.2147/CEG.S31275
PMCID: PMC3401056  PMID: 22826640
deep sedation; propofol; endoscopic retrograde cholangiopancreatography; endoscopic ultrasonography; elderly; developing country
2.  Propofol versus Midazolam for Sedation during Esophagogastroduodenoscopy in Children 
Clinical Endoscopy  2013;46(4):368-372.
Background/Aims
To evaluate the efficacy and safety of propofol and midazolam for sedation during esophagogastroduodenoscopy (EGD) in children.
Methods
We retrospectively reviewed the hospital records of 62 children who underwent ambulatory diagnostic EGD during 1-year period. Data were collected from 34 consecutive patients receiving propofol alone. Twenty-eight consecutive patients who received sedation with midazolam served as a comparison group. Outcome variables were length of procedure, time to recovery and need for additional supportive measures.
Results
There were no statistically significant differences between the two groups in age, weight, sex, and the length of endoscopic procedure. The recovery time from sedation was markedly shorter in propofol group (30±16.41 minutes) compared with midazolam group (58.89±17.32 minutes; p<0.0001). During and after the procedure the mean heart rate was increased in midazolam group (133.04±19.92 and 97.82±16.7) compared with propofol group (110.26±20.14 and 83.26±12.33; p<0.0001). There was no localized pain during sedative administration in midazolam group, though six patients had localized pain during administration of propofol (p<0.028). There was no serious major complication associated with any of the 62 procedures.
Conclusions
Intravenous administered propofol provides faster recovery time and similarly safe sedation compared with midazolam in pediatric patients undergoing upper gastrointestinal endoscopy.
doi:10.5946/ce.2013.46.4.368
PMCID: PMC3746141  PMID: 23964333
Propofol; Midazolam; Endoscopy, digestive system; Child
3.  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.
doi:10.3748/wjg.v19.i22.3439
PMCID: PMC3683682  PMID: 23801836
Endoscopy; Deep sedation; Anesthetic administration; Anesthetic dose; Adverse effects
4.  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.
doi:10.3748/wjg.v18.i38.5389
PMCID: PMC3471107  PMID: 23082055
Colonoscopy; Deep sedation; Propofol; Hypoventilation; Blood gas monitoring; Transcutaneous
5.  Dexmedetomidine use in the ICU: Are we there yet? 
Critical Care  2013;17(3):320.
Expanded abstract
Citation
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.
Background
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.
Methods
Objective
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.
Design
Two phase 3 multicenter, randomized, double-blind trials were conducted.
Setting
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.
Subjects
The subjects were adult ICU patients who were receiving mechanical ventilation and who needed light to moderate sedation for more than 24 hours.
Intervention
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.
Outcomes
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.
Results
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).
Conclusions
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.
doi:10.1186/cc12707
PMCID: PMC3706806  PMID: 23731973
6.  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.
Background
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.
Methods
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.
Results
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.
Conclusions
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)
doi:10.1186/1471-230X-12-164
PMCID: PMC3607964  PMID: 23170921
Balanced propofol sedation; Alfentanil; Fentanyl; Deep sedation; Diagnostic endoscopy; Cost benefit
7.  Propofol for procedural sedation in the emergency department 
Emergency Medicine Journal : EMJ  2007;24(7):459-461.
Objectives
To observe procedural sedation practice within a district general hospital emergency department (ED) that uses propofol for procedural sedation.
Methods
Prospective observation of procedural sedation over an 11 month period. Patients over 16 years of age requiring procedural sedation and able to give informed consent were recruited. The choice of sedation agent was at the discretion of the physician. The following details were recorded on a standard proforma for each patient: indication for procedural sedation; agent used; depth and duration of sedation; ease of reduction; use of a reversal agent; complications and reasons for delayed discharge from the ED.
Results
48 patients were recruited; propofol was used in 32 cases and midazolam in 16 cases. The median period of sedation was considerably shorter in the propofol group (3 vs 45 min) but this did not confer a shorter median time in the ED (200 vs 175 min). There were no documented cases of over‐sedation in the propofol group; however, four patients in the midazolam group were over‐sedated, three requiring reversal with flumazenil. There were no other significant complications in either group. There was no difference in the median depth of sedation achieved or ease of reduction between the two groups.
Conclusions
Propofol is effective and safe for procedural sedation in the ED. Propofol has a considerably shorter duration of action than midazolam, thereby shortening the period of sedation.
doi:10.1136/emj.2007.046714
PMCID: PMC2658387  PMID: 17582032
8.  Comparison of Midazolam Alone versus Midazolam Plus Propofol during Endoscopic Submucosal Dissection 
Clinical Endoscopy  2011;44(1):22-26.
Background/Aims
For proper sedation during endoscopic submucosal dissection (ESD), propofol has been widely used. This study aimed to compare the levels of sedation and tolerance of patients treated with midazolam (M group) and a combination of midazolam and propofol (MP group) during ESD.
Methods
A total of 44 consecutive patients undergoing ESD were randomly assigned to the two groups. In the M group, 2 mg of midazolam was given repeatedly to maintain after a loading dose of 5 mg. The MP group initially received 5 mg of midazolam and 20 mg of propofol. Then, we increased the dosage of propofol by 20 mg gradually.
Results
The average amount of midazolam was 12 mg in the M group. In the M group, 10 patients were given propofol additionally, since they failed to achieve proper sedation. The average amount of propofol was 181 mg in the MP group. Procedure time, vital signs and rates of complications were not significantly different between two groups. Movement of patients and discomfort were lower in the MP group.
Conclusions
During ESD, treatment with propofol and a low dose of midazolam for sedation provides greater satisfaction for endoscopists compared to midazolam alone.
doi:10.5946/ce.2011.44.1.22
PMCID: PMC3363047  PMID: 22741108
Endoscopic submucosal dissection; Sedation; Midazolam; Propofol
9.  Propofol-Based Sedation Does Not Increase Rate of Complication during Percutaneous Endoscopic Gastrostomy Procedure 
Objectives. To evaluate and compare the complication rate of sedation with or without propofol regimen for percutaneous endoscopic gastrostomy (PEG) in a hospital in Thailand. Subjects and Methods. A total of 198 patients underwent PEG procedures by using intravenous sedation (IVS) from Siriraj Hospital, Thailand from August 2006 to January 2009. The primary outcome variable was the overall complication rate. The secondary outcome variables were sedation and procedure related complications, and mortality rate. Results. After matching ASA physical status and indications of procedure, there were 92 PEG procedures in propofol based sedation group (A) and 20 PEG procedures in non-propofol based sedation group (B). All sedation was given by residents or anesthetic nurses directly supervised by staff anesthesiologist in the endoscopy room. There were no significant differences in patients' characteristics, sedation time, indication, complications, anesthetic personnel and mortality rate between the two groups. All complications were easily treated, with no adverse sequelae. Mean dose of fentanyl and midazolam in group A was significantly lower than in group B. Conclusion. Propofol-based sedation does not increase rate of complication during PEG procedure. Additionally, IVS of PEG procedure is relatively safe and effective when performed by physicians in training. Serious complications are none.
doi:10.1155/2011/134819
PMCID: PMC2929499  PMID: 20811547
10.  Ketamine and midazolam sedation for pediatric gastrointestinal endoscopy in the Arab world 
AIM: To evaluate the safety and effectiveness of intravenous ketamine-midazolam sedation during pediatric endoscopy in the Arab world.
METHODS: A retrospective cohort study of all pediatric endoscopic procedures performed between 2002-2008 at the shared endoscopy suite of King Abdullah University Hospital, Jordan University of Science & Technology, Jordan was conducted. All children were > 1 year old and weighed > 10 kg with American Society of Anesthesiologists class 1 or 2. Analysis was performed in terms of sedation-related complications (desaturation, respiratory distress, apnea, bradycardia, cardiac arrest, emergence reactions), adequacy of sedation, need for sedation reversal, or failure to complete the procedure.
RESULTS: A total of 301 patients (including 160 males) with a mean age of 9.26 years (range, 1-18 years) were included. All were premedicated with atropine; and 79.4% (239/301) had effective and uneventful sedation. And 248 (82.4%) of the 301 patients received a mean dose of 0.16 mg/kg (range, 0.07-0.39) midazolam and 1.06 mg/kg (range, 0.31-2.67) ketamine, respectively within the recommended dosage guidelines. Recommended maximum midazolam dose was exceeded in 17.6% patients [34 female (F):19 male (M), P = 0.003] and ketamine in 2.7% (3 M:5 F). Maximum midazolam dose was more likely to be exceeded than ketamine (P < 0.001). Desaturation occurred in 37 (12.3%) patients, and was reversible by supplemental oxygen in all except 4 who continue to have desaturation despite supplemental oxygen. Four (1.3%) patients had respiratory distress and 6 (2%) were difficult to sedate and required a 3rd sedative; 12 (4%) required reversal and 7 (2.3%) failed to complete the procedure. None developed apnea, bradycardia, arrest, or emergence reactions.
CONCLUSION: Ketamine-midazolam sedation appears safe and effective for diagnostic pediatric gastrointestinal endoscopy in the Arab world for children aged > 1 year and weighing > 10 kg without co-morbidities.
doi:10.3748/wjg.v17.i31.3630
PMCID: PMC3180020  PMID: 21987610
Pediatric endoscopy; Sedation; Ketamine; Arab
11.  Is it safe to use propofol in the emergency department? A randomized controlled trial to compare propofol and midazolam 
Background
This study examined the safety and effectiveness of the procedural sedation analgesia (PSA) technique carried out in the emergency department (ED) of a university hospital over a period of 1 year. The research was done to compare the effectiveness and efficacy of moderate sedation of fentanyl combined with either midazolam or propofol for any brief, intense procedure in the ED setting.
Aims
The objectives were to observe the occurrence of adverse events in subjects undergoing PSA for intense and painful procedures in the emergency department and to implement the use of capnography as a method of monitoring the patients when they were under PSA.
Methods
Forty patients were selected for this study. They were randomly divided into two equal groups using the computer-generated random permuted blocks of four patients. Twenty patients were grouped together as group A and the remaining 20 patients as group B. Drugs used were single blinded to prevent any bias. Drug A was propofol and fentanyl, while drug B was midazolam and fentanyl. The procedures involved included orthopedic manipulation such as reduction of fractures, reduction of dislocated joints, abscess drainage, wound debridement, laceration wound repair and cardioversion. All of the subjects were monitored for their vital signs and end tidal carbon dioxide level every 10 min till the PSA was completed. The duration of stay in the ED was documented when the subjects had completed the procedure and were released from the department.
Result
Of the study population, 75.6% were males. The mean age was 37.8 years (95% CI 33.2, 39.8). None of the patients developed any major complications while under PSA. The vital signs pre-, intra- and post-procedure were not significantly different in either the propofol or mizadolam groups (p value >0.05).
Conclusion
This study had proven that there was no difference in adverse event occurrence between the studied drugs during PSA. Propofol can be recommended for use in PSA if the operator is well trained and familiar with the drug.
doi:10.1007/s12245-010-0162-3
PMCID: PMC2885259  PMID: 20606819
Procedural sedation analgesia; Midazolam; Propofol; Emergency department
12.  Deep sedation for endoscopic retrograde cholangiopancreatography: a comparison between clinical assessment and NarcotrendTM monitoring 
Introduction
Moderate to deep sedation is generally used for endoscopic retrograde cholangiopancreatography (ERCP). The depth of sedation is usually judged by clinical assessment and electroencephalography-guided monitoring. The aim of this study was to compare the clinical efficacy of clinical assessment and NarcotrendTM monitoring during deep-sedated ERCP.
Methods
One hundred patients who underwent ERCP in a single year were randomly assigned to either group C or group N. Patients in group C (52) were sedated using the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale. Patients in group N (48) were sedated using the NarcotrendTM system. The MOAA/S scale 1 or 2 and the NarcotrendTM index 47–56 to 57–64 were maintained during the procedure. The primary outcome variable of the study was the successful completion of the endoscopic procedure. The secondary outcome variables were the total dose of propofol used during the procedure, complications during and immediately after procedure, and recovery time.
Results
All endoscopies were completed successfully. The mean total dose of propofol in group C was significantly lower than that in group N. However, the mean dose of propofol, expressed as dose/kg or dose/kg/h in both groups, was not significantly different (P = 0.497, 0.136). Recovery time, patient tolerance and satisfaction, and endoscopist satisfaction were comparable between the two groups. All sedation-related adverse events during and immediately after the procedure, such as hypotension, hypertension, tachycardia, bradycardia, transient hypoxia, and upper airway obstruction, in group C (62.2%) were significantly higher than in group N (37.5%) (P = 0.028).
Conclusion
Clinical assessment and NarcotrendTM-guided sedation using propofol for deep sedation demonstrated comparable propofol dose and recovery time. Both monitoring systems were equally safe and effective. However, the NarcotrendTM-guided sedation showed lower hemodynamic changes and fewer complications compared with the clinical assessment-guided sedation.
doi:10.2147/MDER.S17236
PMCID: PMC3417873  PMID: 22915929
deep sedation; endoscopic retrograde cholangiopancreatography; clinical assessment; NarcotrendTM monitoring
13.  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.
doi:10.3748/wjg.v18.i43.6284
PMCID: PMC3501778  PMID: 23180950
Conscious sedation; Bispectral index monitors; Pancreatic neoplasm; Endoscopic retrograde cholangiopancreatography
14.  Comparison between Midazolam Used Alone and in Combination with Propofol for Sedation during Endoscopic Retrograde Cholangiopancreatography 
Clinical Endoscopy  2014;47(1):94-100.
Background/Aims
Endoscopic retrograde cholangiopancreatography (ERCP) is an uncomfortable procedure that requires adequate sedation for its successful conduction. We investigated the efficacy and safety of the combined use of intravenous midazolam and propofol for sedation during ERCP.
Methods
A retrospective review of patient records from a single tertiary care hospital was performed. Ninety-four patients undergoing ERCP received one of the two medication regimens, which was administered by a nurse under the supervision of a gastroenterologist. Patients in the midazolam (M) group (n=44) received only intravenous midazolam, which was titrated to achieve deep sedation. Patients in the midazolam pulse propofol (MP) group (n=50) initially received an intravenous combination of midazolam and propofol, and then propofol was titrated to achieve deep sedation.
Results
The time to the initial sedation was shorter in the MP group than in the M group (1.13 minutes vs. 1.84 minutes, respectively; p<0.001). The recovery time was faster in the MP group than in the M group (p=0.031). There were no significant differences between the two groups with respect to frequency of adverse events, pain experienced by the patient, patient discomfort, degree of amnesia, and gag reflex. Patient cooperation, rated by the endoscopist as excellent, was greater in the MP group than in the M group (p=0.046).
Conclusions
The combined use of intravenous midazolam and propofol for sedation during ERCP is more effective than midazolam alone. There is no difference in the safety of the procedure.
doi:10.5946/ce.2014.47.1.94
PMCID: PMC3928499  PMID: 24570889
Propofol; Midazolam; Cholangiopancreatography, endoscopic retrograde; Conscious sedation
15.  Sedation in gastrointestinal endoscopy: Current issues 
Diagnostic and therapeutic endoscopy can successfully be performed by applying moderate (conscious) sedation. Moderate sedation, using midazolam and an opioid, is the standard method of sedation, although propofol is increasingly being used in many countries because the satisfaction of endoscopists with propofol sedation is greater compared with their satisfaction with conventional sedation. Moreover, the use of propofol is currently preferred for the endoscopic sedation of patients with advanced liver disease due to its short biologic half-life and, consequently, its low risk of inducing hepatic encephalopathy. In the future, propofol could become the preferred sedation agent, especially for routine colonoscopy. Midazolam is the benzodiazepine of choice because of its shorter duration of action and better pharmacokinetic profile compared with diazepam. Among opioids, pethidine and fentanyl are the most popular. A number of other substances have been tested in several clinical trials with promising results. Among them, newer opioids, such as remifentanil, enable a faster recovery. The controversy regarding the administration of sedation by an endoscopist or an experienced nurse, as well as the optimal staffing of endoscopy units, continues to be a matter of discussion. Safe sedation in special clinical circumstances, such as in the cases of obese, pregnant, and elderly individuals, as well as patients with chronic lung, renal or liver disease, requires modification of the dose of the drugs used for sedation. In the great majority of patients, sedation under the supervision of a properly trained endoscopist remains the standard practice worldwide. In this review, an overview of the current knowledge concerning sedation during digestive endoscopy will be provided based on the data in the current literature.
doi:10.3748/wjg.v19.i4.463
PMCID: PMC3558570  PMID: 23382625
Gastrointestinal endoscopy; Endoscopy; Sedation; Analgesia; Digestive system
16.  Retrospective Review of Propofol Dosing for Procedural Sedation in Pediatric Patients 
OBJECTIVES
The purpose of this study was to determine the total propofol dose (mg/kg) for non-emergent pediatric procedural sedation and evaluate dosing differences with regard to a patient's sex, age, and body mass index. Adverse events were recorded and evaluated to determine whether certain patient groups were at a higher risk than others.
METHODS
This study was a retrospective observational pilot study including patients 0 to 18 years of age admitted between January 2008 and November 2009 for non-emergent gastrointestinal endoscopic procedures or radiologic imaging, who received propofol for procedural sedation. Data gathered included sex, age, height, weight, chronic medical conditions and medication use, concomitant anesthetic gas, preprocedure midazolam, procedure length, propofol dose in mg/kg, other medications administered during procedure, and adverse events that occurred. Comparisons between adverse event groups and categories of baseline characteristics were made using the Wilcoxon signed-rank, Kruskal-Wallis nonparametric and Pearson's chisquare tests, as appropriate.
RESULTS
A total of 101 patients met inclusion criteria and were included in the analysis. The mean dose of propofol required for female patients was 3.7 mg/kg versus 3.4 mg/kg for males (p=0.3). The mean dose of propofol for patients ≤9 years, 10 to 12 years, and >12 years was 3.2, 3.9, and 3.9 mg/kg, respectively (p=0.25). The mean dose of propofol for underweight, healthy weight, overweight, and obese patients was 4.2, 3.9, 3.6, and 2.6 mg/kg, respectively (p=0.38). Hypotension occurred in 42.6% of patients, and bradycardia occurred in 13.9% of patients.
CONCLUSIONS
There were no differences in dose requirements based on sex or age. The difference in dosing between different body weight categories was not statistically significant. The dose of propofol was higher in patients that experienced bradycardia and hypotension, but there was no statistical significance. Given the above, future studies with larger sample sizes should be conducted to establish if statistical significance exists.
doi:10.5863/1551-6776-17.3.246
PMCID: PMC3526928  PMID: 23258967
computed tomography; endoscopy; gastrointestinal; magnetic resonance imaging; pediatrics; propofol
17.  Stepwise sedation for elderly patients with mild/moderate COPD during upper gastrointestinal endoscopy 
AIM: To investigate stepwise sedation for elderly patients with mild/moderate chronic obstructive pulmonary disease (COPD) during upper gastrointestinal (GI) endoscopy.
METHODS: Eighty-six elderly patients with mild/moderate COPD and 82 elderly patients without COPD scheduled for upper GI endoscopy were randomly assigned to receive one of the following two sedation methods: stepwise sedation involving three-stage administration of propofol combined with midazolam [COPD with stepwise sedation (group Cs), and non-COPD with stepwise sedation (group Ns)] or continuous sedation involving continuous administration of propofol combined with midazolam [COPD with continuous sedation (group Cc), and non-COPD with continuous sedation (group Nc)]. Saturation of peripheral oxygen (SpO2), blood pressure, and pulse rate were monitored, and patient discomfort, adverse events, drugs dosage, and recovery time were recorded.
RESULTS: All endoscopies were completed successfully. The occurrences of hypoxemia in groups Cs, Cc, Ns, and Nc were 4 (9.3%), 12 (27.9%), 3 (7.3%), and 5 (12.2%), respectively. The occurrence of hypoxemia in group Cs was significantly lower than that in group Cc (P < 0.05). The average decreases in value of SpO2, systolic blood pressure, and diastolic blood pressure in group Cs were significantly lower than those in group Cc. Additionally, propofol dosage and overall rate of adverse events in group Cs were lower than those in group Cc. Finally, the recovery time in group Cs was significantly shorter than that in group Cc, and that in group Ns was significantly shorter than that in group Nc (P < 0.001).
CONCLUSION: The stepwise sedation method is effective and safer than the continuous sedation method for elderly patients with mild/moderate COPD during upper GI endoscopy.
doi:10.3748/wjg.v19.i29.4791
PMCID: PMC3732854  PMID: 23922479
Upper gastrointestinal endoscopy; Adverse events; Sedation; Monitoring; Chronic obstructive pulmonary disease
18.  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.
Background/Aims
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.
Methods
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).
Results
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).
Conclusions
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.
doi:10.5009/gnl.2012.6.4.464
PMCID: PMC3493727  PMID: 23170151
Deep sedation; Propofol; Midazolam; Endoscopy; Gastrointestinal
19.  Negative impact of sedation on esophagogastric junction evaluation during esophagogastroduodenoscopy 
AIM: To compare the esophagogastric junction (EGJ) areas observed in sedated and non-sedated patients during esophagogastroduodenoscopy (EGD).
METHODS: Data were collected prospectively from consecutive patients who underwent EGD for various reasons. The patients were divided into three groups according to the sedation used: propofol, midazolam, and control (no sedation). The EGJ was observed during both insertion and withdrawal of the endoscope. The extent of the EGJ territory observed was classified as excellent, good, fair, or poor. In addition, the time the EGJ was observed was estimated.
RESULTS: The study included 103 patients (50 males; mean age 58.44 ± 10.3 years). An excellent observation was achieved less often in the propofol and midazolam groups than in the controls (27.3%, 28.6% and 91.4%, respectively, P < 0.001). There was a significant difference in the time at which EGJ was observed among the groups (propofol 20.7 ± 11.7 s vs midazolam 16.3 ± 7.3 s vs control 11.6 ± 5.8 s, P < 0.001). Multivariate analysis showed that sedation use was the only independent risk factor for impaired EGJ evaluation (propofol, OR = 24.4, P < 0.001; midazolam, OR = 25.3, P < 0.001). Hiccoughing was more frequent in the midazolam group (propofol 9% vs midazolam 25.7% vs control 0%, P = 0.002), while hypoxia (SaO2 < 90%) tended to occur more often in the propofol group (propofol 6.1% vs midazolam 0% vs control 0%, P = 0.101).
CONCLUSION: Sedation during EGD has a negative effect on evaluation of the EGJ.
doi:10.3748/wjg.v20.i18.5527
PMCID: PMC4017068  PMID: 24833883
Esophagogastric junction; Endoscopy; Esophagus; Propofol; Midazolam
20.  The impact of diphenhydramine and promethazine in patients undergoing advanced upper endoscopic procedures 
Background
Endoscopic retrograde cholangiopancreatography (ERCP ) and endoscopic ultrasound (EUS) procedures are more complex and longer duration than standard endoscopy, requiring deeper levels of sedation. While prior studies have compared standard sedation (meperidine and midazolam) to propofol, no randomized, controlled trials have evaluated the use of adjunct sedatives in these procedures.
Aims
To prospectively compare the use of promethazine and diphenhydramine as adjunct sedatives to standard sedation in patients undergoing advanced endoscopic procedures.
Methods
This was a prospective, randomized, placebo-controlled study in a single, tertiary-care referral center. Promethazine (P), diphenhydramine (B), or normal saline (NS) were given as adjunct sedatives along with meperidine and midazolam in adult patients undergoing upper EUS and/or ERCP procedures. The main outcome measurement was sedation failure.
Results
292 patients (P: 97, B: 93, NS: 102) were randomized over 36 months. No significant differences in sedation failures (P: 8, B: 13, NS: 11, p=0.449) or in the times needed to achieve adequate sedation (P: 11.8 minutes, B: 12.9 minutes, NS: 14.0 minutes, p=0.054) were seen between the groups. Sedation using P (43.7 minutes) was associated with a significantly longer recovery time compared to B (28.0 minutes) or NS (24.5 minutes).
Conclusions
The use of promethazine and diphenhydramine as adjunct sedatives did not improve sedation failure rates or reduce the time needed to achieve sedation in patients undergoing upper EUS or ERCP. Patients with anticipated sedation difficulties should proceed directly to propofol-based sedation.
doi:10.7178/jig.124
PMCID: PMC3896573  PMID: 24498528
promethazine; diphenhydramine; endoscopic retrograde cholangiopancreatography; endoscopic ultrasound; sedation
21.  The Effect of Sedation During Upper Gastrointestinal Endoscopy 
Background/Aim:
We aimed to study whether sedation reduces discomfort during endoscopy and a comparison of longer-acting diazepam with shorter-acting midazolam.
Patients and Methods:
A prospective, randomized, single-blinded study was conducted at the Department of Medicine at Government Medical College and Hospital, Chandigarh, and was completed over a period of 6 months. The patients were randomized to receive either placebo or sedation with midazolam or diazepam before endoscopy. The endoscopist and the observer recording patient’s/physician’s responses were blinded to the drugs administered. Two hundred and fifty two consecutive patients undergoing diagnostic or therapeutic upper gastrointestinal endoscopy were recruited. The patient’s discomfort and the physician’s comfort during the procedure were recorded on a visual analogue scale rated from 1-10 with-in 10 minutes of the procedure by an independent observer. The Patient’s discomfort ratings were further divided into 3 groups, comfortable (score, 1-3), satisfactory (score, 4-7) and uncomfortable (a score of >7). Similarly the physician’s ease of performing the procedure was also recorded on the same scale. This was again divided into 3 groups: easy (score, 1-3), satisfactory (score, 4-7) and difficult (a score of >7).
Results:
Out of the total of 252 patients, 82 patients received no sedation (group I), 85 received diazepam (group II) and 85 received midazolam (group III). There was no statistical difference in the discomfort experienced by the patients during endoscopy when sedation was used (P=0.0754). Out of 252 patients, 49 underwent endoscopic procedures. Nineteen patients were included in group I, 18 in group II and 12 in group III. Only 10 (20%) patients undergoing endoscopic procedures complained of significant discomfort, but there was no difference in the ones undergoing interventions with or without sedation (P=0.854). The physicians were more comfortable in performing endoscopic procedure in sedated patients, however, the difference between patients in group II and group III was not statistically significant (P=0.0461). Both diazepam and midazolam fared equally well in increasing physician’s comfort (P=0.617).
Conclusion:
There was no difference in the patient’s discomfort with regard to the sedative used (midazolam or diazepam). Although endoscopy was easy or satisfactory in the majority of patients in the unsedated as well as the sedated groups, more often the endoscopist found it difficult to do endoscopy on the unsedated patients.
doi:10.4103/1319-3767.70616
PMCID: PMC2995098  PMID: 20871194
Endoscopic procedures; gastrointestinal endoscopy; patient’s perception; sedation
22.  Recall after procedural sedation in the emergency department 
Emergency Medicine Journal : EMJ  2007;24(5):322-324.
Background
Procedural sedation (PS) is common in the emergency department (ED) and ideally patients should have no recall of the procedure.
Aim
To determine the incidence of recall.
Methods
A prospective observational study in an university ED of all patients undergoing PS. Data were collected on a pre‐formatted data sheet. Levels of satisfaction with the sedation by the treating physician and nurse were recorded on a 10 cm visual analogue scale. On recovery, the patient was asked a validated questionnaire to determine the rate of immediate recall and at telephone follow‐up for delayed recall.
Results
125 patients (88 male, 70%) were enrolled and 110 had completed follow‐up. Mean (range) age was 51.6 (13–91) years. Procedures included 84 (67%) orthopaedic reductions and 41 (33%) cardioversions. A wide range of drug combinations were used, including fentanyl/propofol 32 (25.6%), fentanyl/midazolam 30 (24%), fentanyl/midazolam/propofol 16 (12.8%), propofol 13 (10.4%). 87.2% of procedures were successful. A grimace/groan was observed in 61 of 125 (49%). Immediate recall occurred in 9 of 121 (7.4%; 95% CI 3.7 to 14.0) and delayed recall in 5 of 110 (4.5%; 95% CI 1.7 to 10.8). No drug combination was correlated with recall (Spearman's rho = 0.149), nor the presence of a grimace/groan (r = −0.039). Median sedation satisfaction scores were physician 9.0, nurse 10, patient 10. Correlation of delayed recall with patient satisfaction was –0.471 (p<0.001).
Conclusions
Recall following PS in ED is uncommon. There is no association of recall with drugs used or the presence of a grimace/groan. There is high patient satisfaction with PS in the ED.
doi:10.1136/emj.2006.040923
PMCID: PMC2658473  PMID: 17452696
23.  Clinical recovery time from conscious sedation for dental outpatients. 
Anesthesia Progress  2002;49(4):124-127.
For dental outpatients undergoing conscious sedation, recovery from sedation must be sufficient to allow safe discharge home, and many researchers have defined "recovery time" as the time until the patient was permitted to return home after the end of dental treatment. But it is frequently observed that patients remain in the clinic after receiving permission to go home. The present study investigated "clinical recovery time," which is defined as the time until discharge from the clinic after a dental procedure. We analyzed data from 61 outpatients who had received dental treatment under conscious sedation at the Hiroshima University Dental Hospital between January 1998 and December 2000 (nitrous oxide-oxygen inhalation sedation [n = 35], intravenous sedation with midazolam [n = 10], intravenous sedation with propofol [n = 16]). We found that the median clinical recovery time was 40 minutes after nitrous oxide-oxygen sedation, 80 minutes after midazolam sedation, and 52 minutes after propofol sedation. The clinical recovery time was about twice as long as the recovery time described in previous studies. In a comparison of the sedation methods, clinical recovery time differed (P = .0008), being longer in the midazolam sedation group than in the nitrous oxide-oxygen sedation group (P = .018). These results suggest the need for changes in treatment planning for dental outpatients undergoing conscious sedation.
PMCID: PMC2007416  PMID: 12779113
24.  Propofol-based deep sedation for endoscopic retrograde cholangiopancreatography procedure in sick elderly patients in a developing country 
Introduction:
The aim of this study was to evaluate and compare the clinical efficacy of propofol-based deep sedation (PBDS) for endoscopic retrograde cholangiopancreatography (ERCP) procedure in sick (American Society of Anesthesiologists [ASA] physical status III–IV) and nonsick (ASA physical status I–II) elderly patients in a teaching hospital in Thailand.
Methods:
We undertook a retrospective review of the anesthesia or sedation service records of elderly patients who underwent ERCP procedures from October 2007 to September 2008. All patients were classified into two groups according to the ASA physical status. In group A, the patients had ASA physical status I–II, while in group B, the patients had ASA physical status III–IV. The primary outcome variable of the study was the successful completion of the procedure. The secondary outcome variables were sedation-related adverse events during and immediately after the procedure.
Results:
There were 158 elderly patients who underwent ERCP procedure by using PBDS during the study period. Of these, 109 patients were in group A and 49 patients were in group B. There were no significant differences in age, gender, weight, duration of ERCP, indication of procedure, and the mean dose of fentanyl, propofol, and midazolam between the two groups. All patients in both groups successfully completed the procedure except eight patients in group A and three patients in group B (P = 0.781). Overall, respiratory and cardiovascular adverse events in both groups were not significantly different. All adverse events were easily treated, with no adverse sequelae.
Conclusion:
In the setting of a developing country, PBDS for ERCP procedure in sick elderly patients by trained anesthetic personnel with appropriate monitoring was safe and effective. The clinical efficacy of this technique in sick elderly patients was not different or worse than in nonsick elderly patients. Serious adverse events were rare in our population.
doi:10.2147/TCRM.S21519
PMCID: PMC3132095  PMID: 21753887
deep sedation; endoscopic retrograde cholangiopancreatography; propofol (ERCP); sick; elderly; American Society of Anesthesiologists (ASA); developing country
25.  Clinical Effectiveness of an Anesthesiologist-Administered Intravenous Sedation Outside of the Main Operating Room for Pediatric Upper Gastrointestinal Endoscopy in Thailand 
Objectives. To review our sedation practice and to evaluate the clinical effectiveness of an anesthesiologist-administered intravenous sedation outside of the main operating room for pediatric upper gastrointestinal endoscopy (UGIE) in Thailand. Subjects and Methods. We undertook a retrospective review of the sedation service records of pediatric patients who underwent UGIE. All endoscopies were performed by a pediatric gastroenterologist. All sedation was administered by staff anesthesiologist or anesthetic personnel. Results. A total of 168 patients (94 boys and 74 girls), with age from 4 months to 12 years, underwent 176 UGIE procedures. Of these, 142 UGIE procedures were performed with intravenous sedation (IVS). The mean sedation time was 23.2 ± 10.0 minutes. Propofol was the most common sedative drugs used. Mean dose of propofol, midazolam and fentanyl was 10.0 ± 7.5 mg/kg/hr, 0.2 ± 0.2 mg/kg/hr, and 2.5 ± 1.2 mcg/kg/hr, respectively. Complications relatively occurred frequently. All sedations were successful. However, two patients became more deeply than intended and required unplanned endotracheal intubation. Conclusion. The study shows the clinical effectiveness of an anesthesiologist-administered IVS outside of the main operating room for pediatric UGIE in Thailand. All complications are relatively high. We recommend the use of more sensitive equipments such as end tidal CO2 and carefully select more appropriate patients.
doi:10.1155/2010/748564
PMCID: PMC2929513  PMID: 20811603

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