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1.  Comparison of Procedural Sedation for the Reduction of Dislocated Total Hip Arthroplasty 
Introduction: Various types of sedation can be used for the reduction of a dislocated total hip arthroplasty. Traditionally, an opiate/benzodiazepine combination has been employed. The use of other pharmacologic agents, such as etomidate and propofol, have more recently gained popularity. Currently no studies directly comparing these sedation agents have been carried out. The purpose of this study is to compare differences in reduction and sedation outcomes, including recovery times, of these 3 sedation agents.
Methods: We performed a retrospective chart review examining 198 patients who presented with dislocated total hip arthroplasty at 2 academic affiliated medical centers. The patients were grouped according to the type of sedation agent. We calculated percentages of reduction and sedation complications along with recovery times. Reduction complications included fracture, skin or neurovascular injury, and failure of reduction requiring general anesthesia. Sedation complications included use of bag-valve mask and artificial airway, intubation, prolonged recovery, use of a reversal agent, and inability to achieve sedation. We then compared the data for each sedation agent.
Results: We found reduction complications rates of 8.7% in the propofol, 24.7% in the etomidate, and 28.9% in the opiate/benzodiazepine groups. The propofol group was significantly different from the other 2agents (p ≤ 0.01). Sedation complications were found 7.3% of the time in the propofol , 11.7% in the etomidate , and 21.3% in the opiate/benzodiazepine group, (p=0.02 propofol vs. others) . Average recovery times were 25.2 minutes for propofol, 30.8 minutes for etomidate, and 44.4 minutes for opiate/benzodiazepine (p = 0.05 for propofol vs. other agents).
Conclusion: For reduction of dislocated total hip arthroplasty under procedural sedation, propofol appears to have fewer complications and a trend toward more rapid recovery than both etomidate and opiate/benzodiazepine. These data support the use of propofol as first line agent for procedural sedation of dislocated total hip arthroplasty, with fewer complications and a shorter recovery period.
doi:10.5811/westjem.2013.7.15616
PMCID: PMC3952894  PMID: 24696752
2.  Impact of the United States propofol ban on emergency providers’ procedural sedation agent choice and patient length of stay 
BACKGROUND:
In the recent past, propofol was temporarily removed from the emergency department (ED) for use in procedural sedation. We sought to determine which agents replaced it in clinical practice and the impact this change had on turnaround times (TAT) for sedated patients.
METHODS:
This study is a retrospective chart review at a level one trauma center. Patients receiving sedative agents (propofol, ketamine, midazolam, and etomidate) were identified by pharmacy codes, and their charts were then reviewed for demographics and TAT. Propofol was unavailable in the emergency department (ED) between May 2010 and February 2011. The study period extended from May 2009 until May 2011. Patients receiving sedation by non-emergency medicine physicians and those receiving sedation related to intubation were excluded.
RESULTS:
In total 2466 charts were reviewed and 209 met inclusion criteria. When propofol was available, the most commonly used sedative agent was etomidate (40%), followed by propofol (28%), ketamine (20%), and midazolam (6%). When propofol was unavailable, etomidate remained the most commonly used agent (43%), followed by ketamine (41%), and midazolam (11%). When propofol was available, the median TAT for sedated patients was 163 minutes compared to 178 minutes when propofol was unavailable (P=0.83). When propofol was the primary sedative agent used, the median TAT was 166 minutes as compared with a median TAT of 172 minutes for all other sedative agents combined (P=0.87).
CONCLUSION:
When propofol was unavailable, ketamine became a preferred ED sedation agent. Removal of propofol from the sedation armamentarium did not affect ED TAT.
doi:10.5847/wjem.j.issn.1920-8642.2012.03.003
PMCID: PMC4129780  PMID: 25215059
Procedural sedation; Turnaround time; Propofol; Ketamine; Etomidate; Midazolam
3.  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
4.  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
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.  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
7.  Conscious Sedation and Emergency Department Length of Stay: A Comparison of Propofol, Ketamine, and Fentanyl/Versed 
Study Objectives:
Three of the most commonly used agents for conscious sedation in the Emergency Department (ED) are ketamine, fentanyl/versed, and propofol. In this study, we measured and compared the total times spent in the ED with each of these agents. Our objective was to determine whether the use of propofol for conscious sedation was associated with a shorter length of ED stay as compared to the other two agents.
Methods:
This was a consecutive case series. All patients who required procedural conscious sedation who presented to the ED at University of California, Irvine Medical Center from January 2003 through April 2004 were included in the study. The attending ED physician evaluated the patient and determined which medication(s) would be administered. All patients underwent procedural sedation according to the ED’s standardized sedation protocol. The times and dosages of administered medications and the sedation/consciousness level (SCL) scores were recorded by ED nurses at 3–5 minute intervals. Data was abstracted prospectively. The time to sedation (first dose of agent to SCL score of 2 or less) and time to recovery (last dose of agent to SCL score of 4) of the different regimens were then analyzed and compared.
Results:
Thirty-eight patients received propofol, 38 received ketamine, and 14 received fentanyl/versed. The mean times to sedation (minutes) were: propofol 4.5 (95% CI: 3.3–5.7), ketamine 10.6 (95% CI: 5.8–15.4), fentanyl/versed 11.5 (95% CI: 3.5–19.4). The mean times to recovery were: propofol 21.6 (95% CI: 16.1–27.1), ketamine 55.4 (95% CI: 46.2–64.5), fentanyl/versed 59.9 (95% CI: 20.3–99.5). Propofol had a statistically significant shorter time to sedation than both ketamine (p<.001) and fentanyl/versed (p=.022). Propofol also produced shorter recovery times than both ketamine (p<.001) and fentanyl/versed (p=.002).
Conclusion:
In this study, sedation and recovery times were shorter with propofol than with ketamine or fentanyl/versed. The use of propofol for conscious sedation in this non-randomized study was associated with a shorter ED length of stay.
PMCID: PMC2872520  PMID: 20505814
8.  Sedative Efficacy of Propofol in Patients Intubated/Ventilated after Coronary Artery Bypass Graft Surgery 
Background:
Sedation after open heart surgery is important in preventing stress on the heart. The unique sedative features of propofol prompted us to evaluate its potential clinical role in the sedation of post-CABG patients.
Objectives:
To compare propofol-based sedation to midazolam-based sedation after coronary artery bypass graft (CABG) surgery in the intensive care unit (ICU).
Patients and Methods:
Fifty patients who were admitted to the ICU after CABG surgery was randomized into two groups to receive sedation with either midazolam or propofol infusions; and additional analgesia was administered if required. Inclusion criteria were as follows: patients 40-60 years old, hemodynamic stability, ejection fraction (EF) more than 40%; exclusion criteria included patients who required intra-aortic balloon pump or inotropic drugs post-bypass. The same protocol of anesthetic medications was used in both groups. Depth of sedation was monitored using the Ramsay sedation score (RSS). Invasive mean arterial pressure (MAP) and heart rate (HR), arterial blood gas (ABG) and ventilatory parameters were monitored continuously after the start of study drug and until the patients were extubated.
Results:
The depth of sedation was almost the same in the two groups (RSS=4.5 in midazolam group vs 4.7 in propofol group; P = 0.259) but the total dose of fentanyl in the midazolam group was significantly more than the propofol group (12.5 mg/hr vs 4 mg/hr) (P = 0.0039). No significant differences were found in MAP (P = 0.51) and HR (P = 0.41) between the groups. The mean extubation time in patients sedated with propofol was shorter than those sedated with midazolam (102 ± 27 min vs 245 ± 42 min, respectively; P < 0.05) but the ICU discharge time was not shorter (47.5 hr vs 36.3 hr, respectively; P = 0.24).
Conclusions:
Propofol provided a safe and acceptable sedation for post-CABG surgical patients, significantly reduced the requirement for analgesics, and allowed for more rapid tracheal extubation than midazolam but did not result in earlier ICU discharge.
doi:10.5812/aapm.17109
PMCID: PMC3961039  PMID: 24660162
Propofol; Analgesics; Coronary Artery Bypass; Deep Sedation; Midazolam; Airway Extubation; Length of Stay
9.  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
10.  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
11.  Efficiency and safety of inhalative sedation with sevoflurane in comparison to an intravenous sedation concept with propofol in intensive care patients: study protocol for a randomized controlled trial 
Trials  2012;13:135.
Background
State of the art sedation concepts on intensive care units (ICU) favor propofol for a time period of up to 72 h and midazolam for long-term sedation. However, intravenous sedation is associated with complications such as development of tolerance, insufficient sedation quality, gastrointestinal paralysis, and withdrawal symptoms including cognitive deficits. Therefore, we aimed to investigate whether sevoflurane as a volatile anesthetic technically implemented by the anesthetic-conserving device (ACD) may provide advantages regarding ‘weaning time’, efficiency, and patient’s safety when compared to standard intravenous sedation employing propofol.
Method/Design
This currently ongoing trial is designed as a two-armed, monocentric, randomized prospective phase II study including intubated intensive care patients with an expected necessity for sedation exceeding 48 h. Patients are randomly assigned to either receive intravenous sedation with propofol or sevoflurane employing the ACD. Primary endpoint is the comparison of the ‘weaning time’ defined as the time required from discontinuation of the sedating agent until sufficient spontaneous breathing occurs. Moreover, sedation depth evaluated by Richmond Agitation Sedation Scale and parameters of patient’s safety (that is, vital signs, laboratory monitoring of organ function) as well as the duration of mechanical ventilation and overall stay on the ICU are analyzed and compared. An intention-to-treat analysis will be carried out with all patients for whom it will be possible to define a wake-up time. In addition, a per-protocol analysis is envisaged. Completion of patient recruitment is expected by the end of 2012.
Discussion
This clinical study is designed to evaluate the impact of sevoflurane during long-term sedation of critically ill patients on ‘weaning time’, efficiency, and patient’s safety compared to the standard intravenous sedation concept employing propofol.
Trial registration
EudraCT2007-006087-30; ISCRTN90609144
doi:10.1186/1745-6215-13-135
PMCID: PMC3502585  PMID: 22883020
Inhalative sedation; Intravenous sedation; Intensive care; Sevoflurane
12.  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.
Methods:
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.
Results:
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).
Conclusion:
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.
doi:10.4103/0019-5049.138972
PMCID: PMC4155284  PMID: 25197107
Bispectral index monitoring; midazolam; propofol; sedation; spinal anaesthesia
13.  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
14.  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
15.  A prospective study of high dose sedation for rapid tranquilisation of acute behavioural disturbance in an acute mental health unit 
BMC Psychiatry  2013;13:225.
Background
Acute behavioural disturbance (ABD) is a common problem in psychiatry and both physical restraint and involuntary parenteral sedation are often required to control patients. Although guidelines are available, clinical practice is often guided by experience and there is little agreement on which drugs should be first-line treatment for rapid tranquilisation. This study aimed to investigate sedation for ABD in an acute mental healthcare unit, including the effectiveness and safety of high dose sedation.
Methods
A prospective study of parenteral sedation for ABD in mental health patients was conducted from July 2010 to June 2011. Drug administration (type, dose, additional doses), time to sedation, vital signs and adverse effects were recorded. High dose parenteral sedation was defined as greater than the equivalent of 10 mg midazolam, droperidol or haloperidol (alone or in combination), compared to patients receiving 10 mg or less (normal dose). Effective sedation was defined as a fall in the sedation assessment tool score by two or a score of zero or less. Outcomes included frequency of adverse drug effects, time to sedation/tranquilisation and use of additional sedation.
Results
Parenteral sedation was given in 171 cases. A single drug was given in 96 (56%), including droperidol (74), midazolam (19) and haloperidol (3). Effective sedation occurred in 157 patients (92%), and the median time to sedation was 20 min (Range: 5 to 100 min). The median time to sedation for 93 patients receiving high dose sedation was 20 min (5-90 min) compared to 20 min (5-100 min; p = 0.92) for 78 patients receiving normal dose sedation. Adverse effects occurred in 16 patients (9%); hypotension (14), oxygen desaturation (1), hypotension and oxygen desaturation (1). There were more adverse effects in the high dose sedation group compared to the normal dose group [11/93 (12%) vs. 5/78 (6%); p = 0.3]. Additional sedation was given in 9 of 171 patients (5%), seven in the high dose and two in the normal dose groups.
Conclusions
Large initial doses of sedative drugs were used for ABD in just over half of cases and additional sedation was uncommon. High dose sedation did not result in more rapid or effective sedation but was associated with more adverse effects.
doi:10.1186/1471-244X-13-225
PMCID: PMC3848824  PMID: 24044673
Violence; Sedation; Acute psychiatric unit; Droperidol; Benzodiazepine; Antipsychotic
16.  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.
doi:10.2344/12-00001.1
PMCID: PMC3468288  PMID: 23050750
Propofol; Ketamine; Remifentanil; Deep sedation; TIVA
17.  The Use of Propofol as a Sedative Agent in Gastrointestinal Endoscopy: A Meta-Analysis 
PLoS ONE  2013;8(1):e53311.
Objectives
To assess the efficacy and safety of propofol sedation for gastrointestinal endoscopy, we conducted a meta-analysis of randomized controlled trials (RCTs) comparing propofol with traditional sedative agents.
Methods
RCTs comparing the effects of propofol and traditional sedative agents during gastrointestinal endoscopy were found on MEDLINE, the Cochrane Central Register of Controlled Trials, and EMBASE. Cardiopulmonary complications (i.e., hypoxia, hypotension, arrhythmia, and apnea) and sedation profiles were assessed.
Results
Twenty-two original RCTs investigating a total of 1,798 patients, of whom 912 received propofol only and 886 received traditional sedative agents only, met the inclusion criteria. Propofol use was associated with shorter recovery (13 studies, 1,165 patients; WMD –19.75; 95% CI –27.65, 11.86) and discharge times (seven studies, 471 patients; WMD –29.48; 95% CI –44.13, –14.83), higher post-anesthesia recovery scores (four studies, 503 patients; WMD 2.03; 95% CI 1.59, 2.46), better sedation (nine studies, 592 patients; OR 4.78; 95% CI 2.56, 8.93), and greater patient cooperation (six studies, 709 patients; WMD 1.27; 95% CI 0.53, 2.02), as well as more local pain on injection (six studies, 547 patients; OR 10.19; 95% CI 3.93, 26.39). Effects of propofol on cardiopulmonary complications, procedure duration, amnesia, pain during endoscopy, and patient satisfaction were not found to be significantly different from those of traditional sedative agents.
Conclusions
Propofol is safe and effective for gastrointestinal endoscopy procedures and is associated with shorter recovery and discharge periods, higher post-anesthesia recovery scores, better sedation, and greater patient cooperation than traditional sedation, without an increase in cardiopulmonary complications. Care should be taken when extrapolating our results to specific practice settings and high-risk patient subgroups.
doi:10.1371/journal.pone.0053311
PMCID: PMC3540096  PMID: 23308191
18.  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
19.  Safety of midazolam for sedation of HIV-positive patients undergoing colonoscopy 
HIV medicine  2013;14(6):379-384.
Summary
Concerns regarding possible interactions between midazolam and antiretroviral medicines have caused clinicians to use second-line sedatives, such as diazepam, instead. We demonstrated that patients who received midazolam during colonoscopy had similar clinical outcomes as those who received diazepam.
Background
Because of concerns regarding interactions between midazolam and antiretroviral therapy (ART), alternative sedatives are sometimes used during procedural sedation. Our objective was to compare outcomes in patients on ART who received intravenous (IV) midazolam versus IV diazepam, a second-line agent, during colonoscopy.
Methods
We conducted a retrospective analysis of adult HIV-infected patients who underwent colonoscopy over a 3.5-year period. Primary outcomes were sedation duration, nadir systolic blood pressure, nadir oxygen saturation, abnormal cardiac rhythm, and change in level of consciousness using a standardized scale. We calculated rates of adverse events according to benzodiazepine use and identified risk factors for complications using univariate and multivariate analyses.
Results
We identified 136 patients for this analysis: 70 received midazolam-based sedation and 66 received a diazepam-based regimen. There were no significant differences between the two groups with respect to sedation duration (48 versus 45.7 minutes, P = 0.68), nadir systolic blood pressure (97 versus 101.6 mmHg, P = 0.06), nadir oxygen saturation (94.6 versus 94.8%, P = 0.72), or rate of abnormal cardiac rhythm (11.4 versus 19.7%, P = 0.18). More patients in the midazolam group experienced a depressed level of consciousness (91 versus 74%, P = 0.0075), but no patient required reversal of sedation or became unresponsive.
Conclusions
Although IV midazolam interacts with ART, we did not find evidence that patients who received this agent for procedural sedation had clinical outcomes statistically different from those who received diazepam. These findings should be confirmed in prospective studies or in a randomized controlled trial.
doi:10.1111/hiv.12014
PMCID: PMC4120820  PMID: 23332038
Midazolam; HIV; antiretrovirals; colonoscopy; sedation
20.  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
21.  Intravenous ketamine plus midazolam is superior to intranasal midazolam for emergency paediatric procedural sedation 
Objectives—This study compared intranasal midazolam (INM) with a combination of intravenous ketamine and intravenous midazolam (IVKM) for sedation of children requiring minor procedures in the emergency department.
Method—A single blinded randomised clinical trial was conducted in the emergency department of a major urban paediatric hospital. Subjects requiring sedation for minor procedures were randomised to receive either INM (0.4 mg/kg) or intravenous ketamine (1 mg/kg) plus intravenous midazolam (0.1 mg/kg). Physiological variables and two independent measures of sedation (Sedation Score and Visual Analogue Sedation Scale) were recorded before sedation and at regular intervals during the procedure and recovery period. Times to adequate level of sedation and to discharge were compared.
Results—Fifty three patients were enrolled over a 10 month period. Sedation was sufficient to complete the procedures in all children receiving IVKM and in 24 of the 26 receiving INM. Onset of sedation was an average of 5.3 minutes quicker with IVKM than with INM (95%CI 3.2, 7.4 minutes, p<0.001). Children given INM were discharged an average of 19 minutes earlier than those given IVKM (95%CI 4, 33 minutes, p=0.02). Mean Sedation Scores and Visual Analogue Sedation Scale scores for the 30 minutes after drug administration were significantly better in children given IVKM compared with INM (2.4 and 1.8 versus 3.5 and 3.8, respectively). Both doctors and parents were more satisfied with sedation by intravenous ketamine and midazolam.
Conclusions—Intravenous ketamine plus midazolam used in an appropriate setting by experienced personnel provides an excellent means of achieving sedation suitable for most non-painful minor procedures for children in the emergency department. This combination is superior to INM in terms of speed of onset and consistency of effect. INM delivered via aerosol spray has a more variable effect but may still be adequate for the completion of many of these procedures.
doi:10.1136/emj.18.1.39
PMCID: PMC1725505  PMID: 11310461
22.  Propofol versus Midazolam for Upper Gastrointestinal Endoscopy in Cirrhotic Patients: A Meta-Analysis of Randomized Controlled Trials 
PLoS ONE  2015;10(2):e0117585.
Background
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.
Methods
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.
Results
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.
Conclusion
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.
doi:10.1371/journal.pone.0117585
PMCID: PMC4315567  PMID: 25646815
23.  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
24.  Safety and efficacy of analgesia-based sedation with remifentanil versus standard hypnotic-based regimens in intensive care unit patients with brain injuries: a randomised, controlled trial [ISRCTN50308308] 
Critical Care  2004;8(4):R268-R280.
Introduction
This randomised, open-label, observational, multicentre, parallel group study assessed the safety and efficacy of analgesia-based sedation using remifentanil in the neuro-intensive care unit.
Methods
Patients aged 18–80 years admitted to the intensive care unit within the previous 24 hours, with acute brain injury or after neurosurgery, intubated, expected to require mechanical ventilation for 1–5 days and requiring daily downward titration of sedation for assessment of neurological function were studied. Patients received one of two treatment regimens. Regimen one consisted of analgesia-based sedation, in which remifentanil (initial rate 9 μg kg-1 h-1) was titrated before the addition of a hypnotic agent (propofol [0.5 mg kg-1 h-1] during days 1–3, midazolam [0.03 mg kg-1 h-1] during days 4 and 5) (n = 84). Regimen two consisted of hypnotic-based sedation: hypnotic agent (propofol days 1–3; midazolam days 4 and 5) and fentanyl (n = 37) or morphine (n = 40) according to routine clinical practice. For each regimen, agents were titrated to achieve optimal sedation (Sedation–Agitation Scale score 1–3) and analgesia (Pain Intensity score 1–2).
Results
Overall, between-patient variability around the time of neurological assessment was statistically significantly smaller when using remifentanil (remifentanil 0.44 versus fentanyl 0.86 [P = 0.024] versus morphine 0.98 [P = 0.006]. Overall, mean neurological assessment times were significantly shorter when using remifentanil (remifentanil 0.41 hour versus fentanyl 0.71 hour [P = 0.001] versus morphine 0.82 hour [P < 0.001]). Patients receiving the remifentanil-based regimen were extubated significantly faster than those treated with morphine (1.0 hour versus 1.93 hour, P = 0.001) but there was no difference between remifentanil and fentanyl. Remifentanil was effective, well tolerated and provided comparable haemodynamic stability to that of the hypnotic-based regimen. Over three times as many users rated analgesia-based sedation with remifentanil as very good or excellent in facilitating assessment of neurological function compared with the hypnotic-based regimen.
Conclusions
Analgesia-based sedation with remifentanil permitted significantly faster and more predictable awakening for neurological assessment. Analgesia-based sedation with remifentanil was very effective, well tolerated and had a similar adverse event and haemodynamic profile to those of hypnotic-based regimens when used in critically ill neuro-intensive care unit patients for up to 5 days.
doi:10.1186/cc2896
PMCID: PMC522854  PMID: 15312228
analgesia-based sedation; fentanyl; intensive care; morphine; remifentanil
25.  Combined sedation with midazolam/propofol for gastrointestinal endoscopy in elderly patients 
BMC Gastroenterology  2010;10:11.
Background
Although gastrointestinal endoscopy with sedation is increasingly performed in elderly patients, data on combined sedation with midazolam/propofol are very limited for this age group.
Methods
We retrospectively analyzed 454 endoscopic procedures in 347 hospitalized patients ≥ 70 years who had received combined sedation with midazolam/propofol. 513 endoscopic procedures in 397 hospitalized patients < 70 years during the observation period served as controls. Characteristics of endoscopic procedures, co-morbidity, complications and mortality were compared.
Results
Elderly patients had a higher level of co-morbidity and needed lower mean propofol doses for sedation. We observed no major complication and no difference in the number of minor complications. The procedure-associated mortality was 0%; the 28-day mortality was significantly higher in the elderly (2.9% vs. 1.0%).
Conclusions
In this study on elderly patients with high level co-morbidity, a favourable safety profile was observed for a combined sedation with midazolam/propofol with a higher sensitivity to propofol in the elderly.
doi:10.1186/1471-230X-10-11
PMCID: PMC2823646  PMID: 20105314

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