Safety of Propofol versus Nonpropofol-Based Sedation in Children Undergoing Gastrointestinal Endoscopy: A Systematic Review and Meta-Analysis.
ABSTRACT: Background:The majority of children who undergo gastrointestinal (GI) endoscopy require anesthesia or procedural sedation for comfort, cooperation, and procedure efficiency. The safety profile of propofol is not well established in children but has been studied in the literature. Objective:The aim of this study is to evaluate and compare the safety of propofol-only sedation for GI endoscopy procedures to other anesthetic regimes in the pediatric population. Methods:A search was conducted in the MEDLINE, Embase, and Cochrane Library databases. Randomized clinical trials and prospective cohorts were included in the study. Results:No significant difference was noted in total complications between the two cohorts with a pooled OR of 1.31 (95% CI: 0.57-3.04, chi2?=?0.053, I2?=?54.31%). The pooled rate of complications in the studies was 23.4% for those receiving propofol only and 18.2% for those receiving other anesthetic regimens. Sensitivity analysis was performed removing a study with a very different control comparison compared to the rest of the studies included. Once excluded, there was minimal heterogeneity in the remaining studies and a significant difference in overall complications was detected, with more complications seen in the propofol-only group compared to the other anesthetic groups (OR 1.87, 95% CI 1.09-3.20). Conclusion:Significantly higher incidence of cardiorespiratory complications was noted in the propofol-only versus other anesthetic regimens in pediatric patients undergoing GI endoscopy in this meta-analysis. However, the overall quality of the evidence is very low. How to Apply This Knowledge for Routine Clinical Practice:Clinicians providing sedation to a pediatric population for GI endoscopy should consider there may be increased risks when using a propofol-only regimen, but further study is needed.
Project description: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.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.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.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.
Project description:Gastrointestinal endoscopies are invasive and unpleasant procedures that are increasingly being used worldwide. The importance of high quality procedures (especially in colorectal cancer screening), the increasing patient awareness and the expectation of painless examination, increase the need for procedural sedation. The best single sedation agent for endoscopy is propofol which, due to its' pharmacokinetic/dynamic profile allows for a higher patient satisfaction and procedural quality and lower induction and recovery times, while maintaining the safety of traditional sedation. Propofol is an anesthetic agent when used in higher doses than those needed for endoscopy. Because of this important feature it may lead to cardiovascular and respiratory depression and, ultimately, to cardiac arrest and death. Fueled by this argument, concern over the safety of its administration by personnel without general anesthesia training has arisen. Propofol usage seems to be increasing but it's still underused. It is a safe alternative for simple endoscopic procedures in low risk patients even if administered by non-anesthesiologists. Evidence on propofol safety in complex procedures and high risk patients is less robust and in these cases, the presence of an anesthetist should be considered. We review the existing evidence on the topic and evaluate the regional differences on sedation practices.
Project description:OBJECTIVES:Outcomes associated with a sedative regimen comprised ketamine + propofol for pediatric procedural sedation outside of both the pediatric emergency department and operating room are underreported. We used the Pediatric Sedation Research Consortium database to describe a multicenter experience with ketamine + propofol by pediatric sedation providers. DESIGN:Prospective observational study of children receiving IV ketamine + propofol for procedural sedation outside of the operating room and emergency department using data abstracted from the Pediatric Sedation Research Consortium during 2007-2015. SETTING:Procedural sedation services from academic, community, free-standing children's hospitals, and pediatric wards within general hospitals. PATIENTS:Children from birth to less than or equal to 21 years old. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:A total of 7,313 pediatric procedural sedations were performed using IV ketamine + propofol as the primary sedative regimen. Median age was 84 months (range, < 1 mo to ? 21 yr; interquartile range, 36-144); 80.6% were American Society of Anesthesiologists-Physical Status less than III. The majority of sedation was performed in dedicated sedation or radiology units (76.1%). Procedures were successfully completed in 99.8% of patients. Anticholinergics (glycopyrrolate and atropine) or benzodiazepines (midazolam and lorazepam) were used in 14.2% and 41.3%, respectively. The overall adverse event and serious adverse event rates were 9.79% (95% CI, 9.12-10.49%) and 3.47% (95% CI, 3.07-3.92%), respectively. No deaths occurred. Risk factors associated with an increase in odds of adverse event included ASA status greater than or equal to III, dental suite, cardiac catheterization laboratory or radiology/sedation suite location, a primary diagnosis of having a gastrointestinal illness, and the coadministration of an anticholinergic. CONCLUSIONS:Using Pediatric Sedation Research Consortium data, we describe the diverse use of IV ketamine + propofol for procedural sedation in the largest reported cohort of children to date. Data from this study may be used to design sufficiently powered prospective randomized, double-blind studies comparing outcomes of sedation between commonly administered sedative and analgesic medication regimens.
Project description:Drug-induced sleep endoscopy (DISE) involves assessment of the upper airway using a flexible endoscope while patients are in a pharmacologically-induced sleep-like state. The aim of this article is to review the current literature regarding the role of DISE in children with obstructive sleep apnea (OSA). The indications, typical anesthetic protocol, comparison to other diagnostic modalities, scoring systems, and outcomes are discussed.A comprehensive review of literature regarding pediatric DISE up through May 2017 was performed.DISE provides a thorough evaluation of sites of obstruction during sedation. It is typically indicated for children with persistent OSA after tonsillectomy, those with OSA without tonsillar hypertrophy, children with risk factors predisposing then to multiple sites of obstruction, or when sleep-state dependent laryngomalacia is suspected. The dexmedotomidine and ketamine protocol, which replicates non-REM sleep, appears to be safe and is often used for pediatric DISE, although propofol is the most commonly employed agent for DISE in adults. Six different scoring systems (VOTE, SERS, Chan, Bachar, Fishman, Boudewyns) have been used to report pediatric DISE findings, but none is universally accepted.DISE is a safe and useful technique to assess levels of obstruction in children. There is currently no universally-accepted anesthetic protocol or scoring system for pediatric DISE, but both will be necessary in order to provide a consistent method to report findings, enhance communication among providers and optimize surgical outcomes.N/A.
Project description: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.
Project description:AIM:To compare the results of midazolam-ketamine-propofol sedation performed by an endoscopy nurse and anaesthetist during colonoscopy in terms of patient satisfaction and safety. METHODS:American Statistical Association (ASA) I-II 60 patients who underwent colonoscopy under sedation were randomly divided into two groups: sedation under the supervision of an anaesthetist (SSA) and sedation under the supervision of an endoscopy nurse (SSEN). Both groups were initially administered 1 mg midazolam, 50 mg ketamine and 30-50 mg propofol. Continuation of sedation was performed by the anaesthetist in the SSA group and the nurse with a patient-controlled analgesia (PCA) pump in the SSEN group. The total propofol consumption, procedure duration, recovery times, pain using the visual analogue scale (VAS) and satisfaction score of the patients, and side effects were recorded. In addition, the patients were asked whether they remembered the procedure and whether they would prefer the same method in the case of re-endoscopy. RESULTS:Total propofol consumption in the SSEN group was significantly higher (P < 0.05) than that in the SSA group. When the groups were compared in terms of VAS score, recovery time, patient satisfaction, recall of the procedure, re-preference for the same method in case of re-endoscopy, and side effects, there were no significant differences (P > 0.05) between the two groups. No long-term required intervention side effects were observed in either group. CONCLUSION:Colonoscopy sedation in ASA I-II patients can be safely performed by an endoscopy nurse using PCA pump with the incidence of side effects and patient satisfaction levels similar to sedation under anaesthetist supervision.
Project description:To evaluate the effect of sedation depth on drug-induced sleep endoscopy (DISE).Ninety patients with obstructive sleep apnea (OSA) and 18 snorers underwent polysomnography and DISE under bispectral index (BIS)-guided propofol infusion at two different sedation levels: BIS 65-75 (light sedation) and 50-60 (deep sedation).For the patients with OSA, the percentages of velopharynx, oropharynx, hypopharynx, and larynx obstructions under light sedation were 77.8%, 63.3%, 30%, and 33.3%, respectively. Sedation depth was associated with the severity of velopharynx and oropharynx obstruction, oropharynx obstruction pattern, tongue base obstruction, epiglottis anteroposterior prolapse and folding, and arytenoid prolapse. In comparison, OSA severity was associated with the severity of velopharynx obstruction, severity of oropharynx obstruction, and arytenoid prolapse (odds ratio (95% confidence interval); 14.3 (4.7-43.4), 11.7 (4.2-32.9), and 13.2 (2.8-62.3), respectively). A good agreement was noted between similar DISE findings at different times and different observers (kappa value 0.6 to 1, respectively). A high percentage of arytenoid prolapse (46.7% among the patients with OSA under light sedation) was noted.Greater sedative depth increased upper airway collapsibility under DISE assessment. DISE under BIS-guided propofol infusion, and especially a level of 65-75, offers an objective and reproducible method to evaluate upper airway collapsibility. Some findings were induced by drug sedation and need careful interpretation. Specific arytenoid prolapse patterns were noted for which further investigations are warranted.http://www.clinicaltrials.gov, identifier: NCT01100554.A commentary on this article appears in this issue on page 965.
Project description:We aimed to establish the propofol effect-site concentration (Ce) for appropriate sedation by pharmacodynamic analysis and to determine the propofol Ce during occurrence of sedation-related side effects in pediatric patients undergoing brain magnetic resonance imaging (MRI).In 50 pediatric patients scheduled for brain MRI, sedation was induced with 2.0 mg/kg propofol; additional propofol doses were 0.5-1 mg/kg. Propofol Ce was simulated by inputting the propofol administration profiles of patients into a pediatric compartmental model (Choi model). The relationship between propofol Ce and probabilities of sedation and recovery were analyzed using a sigmoidal Emax model. The simulated propofol Ce for sedation-related side effects was investigated. Population model parameters were estimated using the Nonlinear Mixed-Effects Modelling software.The mean values of propofol Ce?? for sedation during the preparation, scanning, and recovery phases were 1.23, 0.43, and 0.39 ?g/mL. The simulated propofol Ce values during oxygen desaturation (SpO? <90%) (3 patients; 6%), hypotension (16 patients; 32%), and bradycardia (12 patients; 24%) were 3.01±0.04, 2.05±0.63, and 2.41±0.89 ?g/mL, respectively.The required propofol Ce?? for applying monitors during the preparation phase before the start of MRI was higher than the propofol Ce?? required during the scanning phase. During low-intensity stimulation phases, such as scanning, propofol bolus dose should be strictly titrated not to exceed the propofol Ce that can lead to oxygen desaturation because of the relatively low propofol Ce (Ce??, 1.43 ?g/mL) required for sedation in most patients.
Project description:BACKGROUND:Endoscopic retrograde cholangiopancreatography (ERCP) requires moderate to deep sedation, usually with propofol. Adverse effects of propofol sedation are relatively common, such as respiratory and cardiovascular depression. This study was conducted to determine if doxapram, a respiratory stimulant, could be used to reduce the incidence of respiratory depression. METHODS:This is a single-center, prospective randomized double-blind study performed in the endoscopy unit of Helsinki University Central Hospital. 56 patients were randomized in a 1:1 ratio to either receive doxapram as an initial 1 mg/kg bolus and an infusion of 1 mg/kg/h (group DOX) or placebo (group P) during propofol sedation for ERCP. Main outcome measures were apneic episodes and hypoxemia (SpO2?<?90%). Mann-Whitney test for continuous variables and Fisher's exact test for discrete variables were used and mixed effects modeling to take into account repeated measurements on the same subject and comparing both changes within a group as a function of time and between the groups. RESULTS:There were no statistically significant differences in apneic episodes (p?=?0.18) or hypoxemia (p?=?0.53) between the groups. There was a statistically significant rise in etCO2 levels in both groups, but the rise was smaller in group P. There was a statistically significant rise in Bispectral Index (p?=?0.002) but not modified Observer's Assessment of Agitation/Sedation (p?=?0.21) in group P. There were no statistically significant differences in any other measured parameters. CONCLUSIONS:Doxapram was not effective in reducing respiratory depression caused by deep propofol sedation during ERCP. Further studies are warranted using different sedation protocols and dosing regimens. Clinical trial registration ClinicalTrials.gov ID NCT02171910.
Project description: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.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.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).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.