Efficacy and Safety of Remimazolam in Endoscopic Sedation-A Systematic Review and Meta-Analysis.
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ABSTRACT:
SUBMITTER: Zhu X
PROVIDER: S-EPMC8350069 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThis meta-analysis was designed to compare the safety and efficiency of remimazolam with those of propofol in patients undergoing gastroscope sedation.MethodsWe searched PubMed, Cochrane Library, Embase, Ovid, Wanfang Database, China National Knowledge Infrastructure, SINOMED, and ClinicalTrials.gov for studies that reported on remimazolam versus propofol for gastroscope sedation from establishment to February 25, 2023. The sedative efficiency and the incidence of adverse events were assessed as outcomes. Version 2 of the Cochrane risk-of-bias assessment tool was used to assess the risk of bias. Review Manager 5.4 and STATA 17 were used to perform all statistical analyses.ResultsA total of 26 randomized controlled trials involving 3,641 patients were included in this meta-analysis. The results showed that remimazolam had a significantly lower incidence of respiratory depression (risk ratio [RR] = 0.40, 95% confidence interval [CI]: 0.28-0.57; p < 0.01, GRADE high), hypoxemia (RR = 0.34, 95% CI: 0.23-0.49; p < 0.01, GRADE high), bradycardia (RR = 0.34, 95% CI: 0.23-0.51; p < 0.01, GRADE high), dizziness (RR = 0.45, 95% CI: 0.31-0.65; p < 0.01, GRADE high), injection site pain (RR = 0.06, 95% CI: 0.03-0.13; p < 0.01, GRADE high), nausea or vomiting (RR = 0.79, 95% CI: 0.62-1.00; p = 0.05, GRADE moderate), and hypotension (RR = 0.36, 95% CI: 0.26-0.48; p < 0.01, GRADE low).ConclusionsRemimazolam can be used safely in gastroscopic sedation and reduces the incidence of respiratory depression, hypoxemia, bradycardia, injection site pain, and dizziness compared with propofol, and doesn't increase the incidence of nausea and vomiting.
| S-EPMC10823673 | biostudies-literature
Project description:Background: Remimazolam is a new ultrashort-acting benzodiazepine. Remimazolam has been approved for procedural sedation by the US Food and Drug Administration in 2020. However, prior trials and the participants they enrolled were limited. Aim: In this meta-analysis, we investigated the effectiveness and adverse events (AEs) of remimazolam during procedural sedation. Materials and Methods: The study protocol was registered (doi: 10.37766/inplasy2020.8.0043), and six databases were searched. We performed meta-analysis, trial sequential analysis (TSA), and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology for judging the certainty of evidence (CoE). Results: A total of five randomized controlled trials with 1,248 participants were included. Compared with the use of midazolam, the utilization of remimazolam resulted in an increase in procedure success rate [odds ratio (OR) = 9.01, 95% confidence interval (CI): 2.35-34.57], a reduction in the application of rescue medication (OR = 13.58, 95% CI: 3.46-53.28), a decrease in time to recovery [minutes, weighted mean difference (WMD) = -5.70, 95% CI: -8.68 to -2.72], and a better cognitive recovery of Hopkins Verbal Learning Test-Revised (WMD = 5.22, 95% CI: 2.88-7.55). No difference was found in completion of procedure (OR = 1.68, 95% CI: 0.72-3.90) with inconclusive in TSA. Despite no difference of total AEs (OR = 0.60, 95% CI: 0.24-1.50), more detailed analysis of AEs remained inconclusive in TSA. The GRADE assessment demonstrated low to very low CoE. Conclusion: Our analysis suggested that remimazolam may be a better choice for procedural sedation than midazolam. Nevertheless, further studies are warranted to conclusively establish its safety.
| S-EPMC8353129 | biostudies-literature
Project description:BackgroundPostinduction hypotension (PIHO) is a hemodynamic abnormality commonly observed during the induction of general anesthesia. Etomidate is considered a safer drug for the induction of anesthesia because it has only minor adverse effects on the cardiovascular and pulmonary systems. Recent evidence indicates that the novel benzodiazepine remimazolam has minimal inhibitory effects on the circulation and respiration. However, the efficacy and safety of remimazolam versus etomidate in the induction of anesthesia are unclear.ObjectiveTo further understand the potential of remimazolam in anesthesia induction, it is necessary to design a meta-analysis to compare its effects versus the classic safe anesthetic etomidate. The aim of this study is to determine which drug has more stable hemodynamics and a lower incidence of PIHO. Our study will also yield data on sedation efficiency, time to loss of consciousness, time to awakening, incidence of injection pain, and postoperative nausea and vomiting with the two drugs.MethodsWe plan to search the Web of Science, Cochrane Library, Embase, PubMed, China National Knowledge Infrastructure, and Wanfang databases from the date of their creation until March 31, 2025. The language is limited to English and Chinese. The search terms are "randomized controlled trials," "etomidate," and "remimazolam." The incidence of PIHO is the primary outcome measure. Secondary outcomes include depth of anesthesia after induction, sedation success rate, time to loss of consciousness, hemodynamic profiles, recovery time, incidence of injection pain, and postoperative nausea and vomiting. Reviews, meta-analyses, case studies, abstracts from conferences, and commentaries will not be included. The heterogeneity of the results will be evaluated by sensitivity and subgroup analyses. RevMan software and Stata software will be used for data analysis. We will evaluate the quality of included studies using version 2 of the Cochrane risk-of-bias tool. The confidence of the evidence will be assessed through the Grading of Recommendations, Assessments, Developments, and Evaluations system.ResultsThe protocol was registered in the international PROSPERO (Prospective Register of Systematic Reviews) registry in November 2023. As of June 2024, we have performed a preliminary article search and retrieval for further review. The review and analyses are expected to be completed in March 2025. We expect to submit manuscripts for peer review by the end of June 2025.ConclusionsBy synthesizing the available evidence and comparing remimazolam and etomidate, we hope to provide valuable insights into the selection of anesthesia-inducing drugs to reduce the incidence of PIHO and improve patient prognosis.Trial registrationPROSPERO CRD42023463120; https://tinyurl.com/333jb8bm.International registered report identifier (irrid)PRR1-10.2196/55948.
| S-EPMC11208827 | biostudies-literature
Project description:BACKGROUND: Peroral endoscopic esophageal myotomy (POEM) represents a less invasive alternative, as compared with conventional laparoscopic Heller myotomy for treating achalasia patients. In the last years, a number of prospective and retrospective experiences with POEM use for achalasia have been published. METHODS: Relevant publications in which patients affected by achalasia underwent POEM treatment were identified by PubMed databases for the period 2010 - 2013. From each study, we extracted the number and type of major complications (defined as those requiring any additional medical or surgical intervention). Data were pooled, using random-effects models. Heterogeneity among studies was assessed by using Cochran's Q and the I (2) statistic. RESULTS: We found 16 studies that provided data on 551 patients. The median surveillance period was 6 months (range: 3-12). The median of mean POEM duration was 156 minutes (range: 42-112). Median myotomy length was 10?cm (range: 6-14). Technical and clinical success were reported in 97% (95% CI: 94-98%) and 93% (407/428; 95% CI: 90-95%). No heterogeneity (I (2?)=?0%) or publication bias was present in both estimates. When limiting the analysis only to adverse events that require medical or surgical interventions, major adverse events occurred in 14% (95% CI: 11-17%); however, only one patient needed post-POEM surgery (0.2%; 95% CI: 0-0.5%). CONCLUSIONS: POEM appeared to be a highly feasible and effective endoscopic treatment for achalasia. Despite POEM being apparently associated with relatively high morbidity, most patients are successfully managed conservatively, so that POEM appears as a very safe procedure; however, POEM should only be performed in centers able to treat POEM complications, such as pneumothorax or pneumoperitoneum.
| S-EPMC4528214 | biostudies-other
Project description:BACKGROUND:Sedation with etomidate or propofol alone during gastroscopy has many side effects. A systematic review and meta-analysis were conducted to evaluate the safety and efficacy of the combined use of propofol and etomidate for sedation during gastroscopy. METHODS:PubMed, Embase, Medline (via Ovid SP), Cochrane library databases, CINAHL (via EBSCO), China Biology Medicine disc (CBMdisc), Wanfang, VIP, and China National Knowledge Infrastructure (CNKI) databases were systematically searched. We included randomized controlled trials (RCTs) comparing the combined use of propofol and etomidate vs etomidate or propofol alone for sedation during gastroscopy. Data were pooled using the random-effects models or fixed-effect model based on heterogeneity. RESULTS:Fifteen studies with 2973 participants were included in the analysis. Compared to propofol alone, the combined use of propofol and etomidate possibly increased recovery time (SMD?=?0.14, 95% CI?=?0.04-0.24; P?=?.005), and the risk for myoclonus (OR?=?3.07, 95% CI?=?1.73-5.44; P?<?.001), injection pain, and nausea and vomiting. Furthermore, compared to propofol alone, the combination of propofol and etomidate produced an apparent beneficial effect for mean arterial pressure (MAP) after anesthesia (SMD?=?1.32, 95% CI?=?0.38-2.26; P?=?.006), SPO2 after anesthesia (SMD?=?0.99, 95% CI?=?0.43-1.55; P?<?.001), apnea or hypoxemia (OR?=?0.16, 95% CI?=?0.08-0.33; P?<?.001), injection pain, and body movement. Further, compared to etomidate alone, the combination of propofol and etomidate reduced the risk for myoclonus (OR?=?0.15, 95% CI?=?0.11-0.22; P?<?.001), body movement, and nausea and vomiting. CONCLUSION:The combination of propofol and etomidate might increase recovery time vs that associated with propofol, but it had fewer side effects on circulation and respiration in patients undergoing gastroscopy. The combined use of propofol and etomidate can improve and produce an apparent beneficial effect on the adverse effects of propofol or etomidate alone, and it was safer and more effective than propofol or etomidate alone.
| S-EPMC6531275 | biostudies-literature
Project description:Background: The efficacy and safety of peroral endoscopic myotomy (POEM) in the treatment of sigmoid-type achalasia is unknown. This meta-analysis aims to explore the clinical outcomes of POEM for sigmoid-type achalasia. Method: We searched all relevant studies published up to September 2020 in PubMed, Embase, and Cochrane library databases. Meta-analyses for clinical success, Eckardt score, angle of esophageal tortuosity, diameter of esophagus, lower esophageal sphincter (LES) pressure, integrated relaxation pressure (IRP), adverse events, and gastroesophageal reflux diseases were performed based on random or fixed-effects models as needed. Results: We found a total of eight studies that provided data on 248 patients. Overall, the pooled clinical success was achieved in 211 sigmoid-type achalasia patients [90.4%; 95% confidence interval (CI), 85.5%-93.8%]. The pre- and post-POEM Eckardt scores, angle of esophageal tortuosity, diameter of esophageal, LES pressure, and IRP were significantly improved (All p < 0.05). The pooled adverse events rate was 13.0% (95% CI, 3.6%-37.4%). The pooled objective confirmation of reflux rate was 41.5% (95% CI, 26.5%-58.3%), and symptomatic reflux rate was 12.5% (95% CI, 8.3%-18.4%). Conclusions: Our current evidence indicated that POEM is an effective and safe therapeutic modality for the treatment of sigmoid-type achalasia.
| S-EPMC8295649 | biostudies-literature
Project description:Vancomycin and teicoplanin are the glycopeptides currently in use for the treatment of infections caused by invasive beta-lactam-resistant gram-positive organisms. We conducted a systematic review and meta-analysis of randomized controlled trials that have compared vancomycin and teicoplanin administered systemically for the treatment of suspected or proven infections. A comprehensive search of trials without year, language, or publication status restrictions was performed. The primary outcome was all-cause mortality. Two reviewers independently extracted the data. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled by using the fixed-effect model (RRs of >1 favor vancomycin). Twenty-four trials were included. All-cause mortality was similar overall (RR, 0.95; 95% CI, 0.74 to 1.21), and there was no significant heterogeneity. In trials that used adequate allocation concealment, the results favored teicoplanin (RR, 0.82; 95% CI, 0.63 to 1.06), while in trials with unknown methods or inadequate concealment, the results favored vancomycin (RR, 3.61; 95% CI, 1.27 to 10.30). The latter trials might have recruited more severely ill patients. No other variable affected the RRs for mortality, including the assessment of glycopeptides administered empirically or for proven infections, neutropenia, the participant's age, and drug dosing. There were no significant differences between teicoplanin and vancomycin with regard to clinical failure (RR, 0.92; 95% CI, 0.81 to 1.05), microbiological failure (RR, 1.24; 95% CI, 0.93 to 1.65), and other efficacy outcomes. Lower RRs (in favor of teicoplanin) for clinical failure were observed with a lower risk of bias and when treatment was initiated for infections caused by gram-positive organisms rather than empirically. Total adverse events (RR, 0.61; 95% CI, 0.50 to 0.74), nephrotoxicity (RR, 0.44; 95% CI, 0.32 to 0.61), and red man syndrome were significantly less frequent with teicoplanin. Teicoplanin is not inferior to vancomycin with regard to efficacy and is associated with a lower adverse event rate than vancomycin.
| S-EPMC2764163 | biostudies-other
Project description:BackgroundEndoscopic sleeve gastroplasty (ESG) has gained momentum as a promising, minimally invasive bariatric therapy worldwide.ObjectiveWe performed the first comprehensive systematic review and meta-analysis of studies to evaluate the efficacy, safety, and procedural technique of ESG.MethodsBibliographic databases were systematically searched for studies assessing patients who underwent ESG for the treatment of obesity. Studies were included if they reported percent total weight loss or percent excess weight loss and the incidence of serious adverse events. Studies with <15 patients, follow-up period <6 months, and overlapping patients were excluded.ResultsEight observational studies with 1859 patients were included. Pooled mean percent total weight loss at 6, 12, and 24 months was 14.86 (95% confidence interval [CI]: 13.83-15.90), 16.43 (95%CI: 15.23-17.63), and 20.01 (95%CI: 16.92-23.11), respectively. Pooled mean percent excess weight loss at 6, 12, and 24 months was 55.75 (95%CI: 50.61-60.89), 61.84 (95%CI: 54.75-68.93), and 60.40 (95%CI: 48.88-71.92), respectively. The pooled incidence of serious adverse events was 2.26% (95%CI 1.25-4.03) and no mortality was reported. Gastrointestinal bleeding and perigastric fluid collection were the most common reported serious adverse events; however, the pooled incidence of both was <1%. Variations in procedural technique were seen, but the full-thickness nature of suturing was reported in all studies. A layer of reinforcement sutures was performed in the majority of studies (n = 6). Limitations include the lack of controlled studies, long-term follow-up data, and standardization of technique.ConclusionESG, a minimally invasive bariatric therapy, is reproducible among centers worldwide with effective weight loss and favorable safety profile outcomes. Controlled studies would be valuable to further corroborate these findings.
| S-EPMC7009311 | biostudies-literature
Project description:ObjectiveTo evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery relative to visual assessment and pulse oximetry alone.Design and settingSystematic literature review and random effects meta-analysis of randomised controlled trials (RCTs) reporting sedation-related adverse event incidence when adding capnography to visual assessment and pulse oximetry in patients undergoing PSA during ambulatory surgery in the hospital setting. Searches for eligible studies published between 1 January 1995 and 31 December 2016 (inclusive) were conducted in PubMed, the Cochrane Library and EMBASE without any language constraints. Searches were conducted in January 2017, screening and data extraction were conducted by two independent reviewers, and study quality was assessed using a modified Jadad scale.InterventionsCapnography monitoring relative to visual assessment and pulse oximetry alone.Primary and secondary outcome measuresPredefined endpoints of interest were desaturation/hypoxaemia (the primary endpoint), apnoea, aspiration, bradycardia, hypotension, premature procedure termination, respiratory failure, use of assisted/bag-mask ventilation and death during PSA.ResultsThe literature search identified 1006 unique articles, of which 13 were ultimately included in the meta-analysis. Addition of capnography to visual assessment and pulse oximetry was associated with a significant reduction in mild (risk ratio (RR) 0.77, 95%?CI 0.67 to 0.89) and severe (RR 0.59, 95%?CI 0.43 to 0.81) desaturation, as well as in the use of assisted ventilation (OR 0.47, 95%?CI 0.23 to 0.95). No significant differences in other endpoints were identified.ConclusionsMeta-analysis of 13 RCTs published between 2006 and 2016 showed a reduction in respiratory compromise (from respiratory insufficiency to failure) during PSA with the inclusion of capnography monitoring. In particular, use of capnography was associated with less mild and severe oxygen desaturation, which may have helped to avoid the need for assisted ventilation.
| S-EPMC5734204 | biostudies-literature
Project description:Background and study aims Malignant disease accounts for up to 80 % of gastric outlet obstruction (GOO) cases, which may be treated with duodenal self-expanding metal stents (SEMS), surgical gastrojejunostomy (GJ), and more recently endoscopic-ultrasound-guided gastroenterostomy (EUS-GE). These three treatments have not been compared head-to-head in a randomized trial. Methods We searched the Embase and MEDLINE databases for studies published January 2015-February 2021 assessing treatment of malignant GOO using duodenal SEMS, endoscopic (EUS-GE) or surgical (laparoscopic or open) GJ. Efficacy outcomes assessed included technical and clinical success rates, GOO recurrence and reintervention. Safety outcomes included procedure-related bleeding or perforation, and stent-related events for the duodenal SEMS and EUS-GE arms. Results EUS-GE had a lower rate of technical success (95.3%) than duodenal SEMS (99.4 %) or surgical GJ (99.9%) ( P = 0.0048). For duodenal SEMS vs. EUS-GE vs. surgical GJ, rates of clinical success (88.9 % vs. 89.0 % vs. 92.3 % respectively, P = 0.49) were similar. EUS-GE had a lower rate of GOO recurrence based on limited data ( P = 0.0036), while duodenal SEMS had a higher rate of reintervention ( P = 0.041). Overall procedural complications were similar (duodenal SEMS 18.7 % vs. EUS-GE 21.9 % vs. surgical GJ 23.8 %, P = 0.32), but estimated bleeding rate was lowest ( P = 0.0048) and stent occlusion rate was highest ( P = 0.0002) for duodenal SEMS. Conclusions Duodenal SEMS, EUS-GE, and surgical GJ showed similar clinical efficacy for the treatment of malignant GOO. Duodenal SEMS had a lower procedure-related bleeding rate but higher rate of reintervention.
| S-EPMC9187371 | biostudies-literature