The safety of remimazolam versus propofol in gastroscopic sedation: a meta-analysis.
Gastroscopic sedation
Meta-analysis
Propofol
Remimazolam
Journal
BMC anesthesiology
ISSN: 1471-2253
Titre abrégé: BMC Anesthesiol
Pays: England
ID NLM: 100968535
Informations de publication
Date de publication:
29 Jan 2024
29 Jan 2024
Historique:
received:
08
05
2023
accepted:
18
01
2024
medline:
30
1
2024
pubmed:
30
1
2024
entrez:
29
1
2024
Statut:
epublish
Résumé
This meta-analysis was designed to compare the safety and efficiency of remimazolam with those of propofol in patients undergoing gastroscope sedation. We 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. A 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). Remimazolam 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.
Sections du résumé
BACKGROUND
BACKGROUND
This meta-analysis was designed to compare the safety and efficiency of remimazolam with those of propofol in patients undergoing gastroscope sedation.
METHODS
METHODS
We 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.
RESULTS
RESULTS
A 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).
CONCLUSIONS
CONCLUSIONS
Remimazolam 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.
Identifiants
pubmed: 38287259
doi: 10.1186/s12871-024-02422-y
pii: 10.1186/s12871-024-02422-y
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
40Informations de copyright
© 2024. The Author(s).
Références
Barkun AN, Almadi M, Kuipers EJ, Laine L, Sung J, Tse F, et al. Management of nonvariceal upper gastrointestinal bleeding: guideline recommendations from the International Consensus Group. Ann Intern Med. 2019;171:805.
pubmed: 31634917
pmcid: 7233308
doi: 10.7326/M19-1795
Abu Baker F, Mari A, Amarney K, Hakeem AR, Ovadia B, Kopelman Y. Propofol sedation in colonoscopy: from satisfied patients to improved quality indicators. Clin Exp Gastroenterol. 2019;12:105–10.
pubmed: 30881077
pmcid: 6396664
doi: 10.2147/CEG.S186393
Li DN, Zhao GQ, Su ZB. Propofol target-controlled infusion in anesthesia induction during painless gastroscopy. J Coll Physicians Surg Pak. 2019;29:604–7.
pubmed: 31253207
doi: 10.29271/jcpsp.2019.07.604
Yuan X, Zhang D, Mao S, Wang Q. Filling the gap in understanding the mechanism of GABAAR and Propofol using computational approaches. J Chem Inf Model. 2021;61:1889–901.
pubmed: 33823589
doi: 10.1021/acs.jcim.0c01290
Kumar G, Stendall C, Mistry R, Gurusamy K, Walker D. A comparison of total intravenous anaesthesia using propofol with sevoflurane or desflurane in ambulatory surgery: systematic review and meta-analysis. Anaesthesia. 2014;69:1138–50.
pubmed: 24847783
doi: 10.1111/anae.12713
Paton DM. Remimazolam: a short-acting benzodiazepine for procedural sedation. Drugs Today. 2021;57:337.
doi: 10.1358/dot.2021.57.5.3264119
Kilpatrick GJ, McIntyre MS, Cox RF, Stafford JA, Pacofsky GJ, Lovell GG, et al. CNS 7056. Anesthesiology. 2007;107:60–6.
pubmed: 17585216
doi: 10.1097/01.anes.0000267503.85085.c0
Chen SH, Yuan TM, Zhang J, Bai H, Tian M, Pan CX, et al. Remimazolam tosilate in upper gastrointestinal endoscopy: a multicenter, randomized, non-inferiority, phase III trial. J Gastroenterol Hepatol. 2020;36:474–81.
pubmed: 32677707
doi: 10.1111/jgh.15188
Liu X, Ding B, Shi F, Zhang Y, Liu L, Sha Y, et al. The efficacy and safety of remimazolam tosilate versus etomidate-propofol in elderly outpatients undergoing colonoscopy: a prospective, randomized, single-blind, non-inferiority trial. Drug Des Devel Ther. 2021;15:4675–85.
pubmed: 34819721
pmcid: 8606755
doi: 10.2147/DDDT.S339535
Pastis NJ, Hill NT, Yarmus LB, Schippers F, Imre M, Sohngen W, et al. Correlation of vital signs and depth of Sedation by Modified Observer’s Assessment of Alertness and Sedation (MOAA/S) scale in bronchoscopy. J Bronchol Interv Pulmonol. 2022;29:54–61.
doi: 10.1097/LBR.0000000000000784
Page MJ, Moher D, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews. BMJ. 2021;372:n160.
pubmed: 33781993
pmcid: 8005925
doi: 10.1136/bmj.n160
Higgins JPT, Eldridge SM, Li T. Chapter 23: Including variants on randomized trials. In: Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). London: The Cochrane Collaboration; 2022.
Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.
pubmed: 31462531
doi: 10.1136/bmj.l4898
Higgins JPT, Li T, Deeks JJ. Chapter 6: Choosing effect measures and computing estimates of effect. In: Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). London: The Cochrane Collaboration; 2022.
Ioannidis JPA. Interpretation of tests of heterogeneity and bias in meta-analysis. J Eval Clin Pract. 2008;14:951–7.
pubmed: 19018930
doi: 10.1111/j.1365-2753.2008.00986.x
Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P, et al. GRADE guidelines: 4. Rating the quality of evidence—study limitations (risk of bias). J Clin Epidemiol. 2011;64:407–15.
pubmed: 21247734
doi: 10.1016/j.jclinepi.2010.07.017
Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines 6. Rating the quality of evidence—imprecision. J Clin Epidemiol. 2011;64:1283–93.
pubmed: 21839614
doi: 10.1016/j.jclinepi.2011.01.012
Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, et al. GRADE guidelines: 7. Rating the quality of evidence—inconsistency. J Clin Epidemiol. 2011;64:1294–302.
pubmed: 21803546
doi: 10.1016/j.jclinepi.2011.03.017
Pogue JM, Yusuf S. Cumulating evidence from randomized trials: utilizing sequential monitoring boundaries for cumulative meta-analysis. Control Clin Trials. 1997;18:580–93.
pubmed: 9408720
doi: 10.1016/S0197-2456(97)00051-2
Guo M, Wang MH, Zhang JY, Zhu Y, Ding YB, Deng B. Efficacy of remimazolam combined with remifentanil used for painless gastroscopy. Chin J Anesthesiol. 2021;41:576–9.
Guo J, Qian Y, Zhang X, Han S, Shi Q, Xu J. Remimazolam tosilate compared with propofol for gastrointestinal endoscopy in elderly patients: a prospective, randomized and controlled study. BMC Anesthesiol. 2022;22:180.
pubmed: 35689208
pmcid: 9185932
doi: 10.1186/s12871-022-01713-6
Guo S, Liu XY, Zhao XY, Li B, He BB, Xu W, et al. Clinical observation of Remimazolam tosylate combined with low-dose propofol in painless gastroscopy. China J Endosc Chin. 2022;28:21–5.
Shi CC, Sun J, Zhang YF. Application of remimazolam in children during painless gastroscopy. J Clin Pathol Res Chin. 2021;41:2918–22.
Shi WY, Cheng Y, He HY, Fang Q, Hu Y, Xu XP, et al. Efficacy and safety of the remimazolam-alfentanil combination for sedation during gastroscopy: a randomized, double-blind, single-center controlled trial. Clin Ther. 2022;44:1506–18.
pubmed: 36763995
doi: 10.1016/j.clinthera.2022.09.014
Teng YP, Li SY, Tian YJ, Liu Y, Wu LN, He JX, et al. Observation on the effects of combined use of nalbuphine and remimazolam for sedation during painless gastroscopy in elderly patients. World Clin DrugsChinese. 2021;42:1088–92.
Zhao J, Lou LL. Remimazolam and propofol combined with sufentanil respectively in patients undergoing painless gastroscopy. Chin Remedies Clin Chin. 2021;21:2143–4.
Cao Y, Chi P, Zhou C, Lv W, Quan Z, Xue FS. Remimazolam tosilate sedation with adjuvant sufentanil in Chinese patients with liver cirrhosis undergoing gastroscopy: a randomized controlled study. Med Sci Monit. 2022;28:e936580.
pubmed: 35706340
pmcid: 9210946
Chen ML, Hu CH, Zhang Y, Long DD. The anesthesia efficacy of remimazolam combined with sufentanil used for painless ultrasound gastroscopy. Drug Eval Chin. 2022;19:944–7.
Cheng XH, Qi LJ, Qu CW, Yang ZZ, Zhao F. Comparison of sedative effects of remimazolam and propofol in painless gastroscopy in elderly patients. China Pract Med Chin. 2022;17:12–5.
Ge Q, Zhao SL, Wang YW, Hui ZC, Qi XT. Effect of different doses of remimazolam on painless gastroscopy in elderly patients. J Clin Anesthesiol Chin. 2022;38:275–8.
He J, Fu BJ, Ye YX, Xiang WY. Clinical utility of remimazolam for painless gastroscopy in patients with liver cirrhosis. Pharm Today Chin. 2022;32:618–22.
Hu B, Jiang K, Shi W, Xiao S, Zhang S, Zhang Y, et al. Effect of remimazolam tosilate on respiratory depression in elderly patients undergoing gastroscopy: a multicentered, prospective, and randomized study. Drug Des Devel Ther. 2022;16:4151–9.
pubmed: 36506792
pmcid: 9733689
doi: 10.2147/DDDT.S391147
Jia T, Wang HJ, Gu SQ, Li HP. Study on the effect of remimazolam compounded with remifentanil on the safety of painless gastroscopy. Dr Chin. 2022;7:35–8.
Kang XX, Wang ZY, Zhou JF, Xu C, Li L, Lv YQ. Application of remimazolam besylate combined with alfentanil in painless gastroscopy in obese patients. J Chin Pract Diagn Ther. 2022;36:744–6.
Li CY, Chen ZY, Xu YL, Liu CY. Application of remimazolam combined with sufentanil in painless ultrasound gastroscopy. Strait Pharm J Chin. 2022;34:76–9.
Liu YH. Effectiveness of remimazolam combined with alfentanil anesthesia for painless gastroscopy. BaoJian WenHui Chin. 2022;23:93–6.
Lu SH, Guo SH. Comparative study on the efficacy and safety of remimazolam tosilate and propofol in painless Ul-trasonic gastroscopy. Guangzhou Med J Chin. 2022;53:22–6.
Ma GS, Chen XH, Cao HZ. Effects of remimazolam on the efficacy in elderly obese patients undergoing painless gastroscopy. J Clin Anesthesiol Chin. 2022;38:1057–60.
Tan YJ, Ouyang W, Tang YZ, Fang N, Fang C, Quan CX. Effect of remimazolam tosilate on early cognitive function in elderly patients undergoing upper gastrointestinal endoscopy. J Gastroenterol Hepatol. 2022;37:576–83.
pubmed: 34907594
pmcid: 9303590
doi: 10.1111/jgh.15761
Xu C, He L, Ren J, Zhou J, Guo H, Chen N, et al. Efficacy and safety of remimazolam besylate combined with alfentanil in painless gastroscopy: a randomized, single-blind, parallel controlled study. Contrast Media Mol Imaging. 2022;2022:1–10.
Yang TS, Wang MH, Wang Q, Peng R, Liu HQ, Zhang JY. Feasibility of using remimazolam alone in painless gastroscopy. J Clin Med Pract Chin. 2022;26:127–30135.
Zhang L, He L, Zhao EX, Li L, Li L, Lv WQ. Efficacy and safety of remimazolam combined with alfentanil in elderly patients undergoing painless gastroscopy. J Zhengzhou Univ Med Sci Chin. 2022;57:689–93.
Zhang Y, Ye G, Zhang L, Li S, Jiang J, Mu JY, et al. Clinical observation of remimazolom for painless gastroscopy sedation in outpatients. China Pharm Chin. 2022;33:492–6.
Wang YX, Liu FX, Wang MH, Guo M, Zhang JY. Efficacy of ideal body mass of remimazolam mesylate combined with remifentanil for painless gastroscopy. Her Med Chin. 2023;42:68–72.
Tang N, Wan MLZ, Wu J, Yang XL. Observasion on effect of remimazolam in painlss gastroscopy of elderly patients at high altitude. China J Phamacoeidemiol Chin. 2023;32:173–7.
Sterne JAC, Sutton AJ, Ioannidis JPA, Terrin N, Jones DR, Lau J, et al. Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials. BMJ. 2011;343(jul22 1):d4002-4002.
pubmed: 21784880
doi: 10.1136/bmj.d4002
Teh J-L, Shabbir A, Yuen S, So JB-Y. Recent advances in diagnostic upper endoscopy. World J Gastroenterol. 2020;26:433–47.
pubmed: 32063692
pmcid: 7002908
doi: 10.3748/wjg.v26.i4.433
Kim S-H, Fechner J. Remimazolam – current knowledge on a new intravenous benzodiazepine anesthetic agent. Korean J Anesthesiol. 2022;75:307–15.
pubmed: 35585830
pmcid: 9346281
doi: 10.4097/kja.22297
Dogan MF, Arslan SO, Yildiz O, Kurtoglu M, Parlar A. Propofol-induced vasodilation in human internal mammary artery: role of potassium channels. J Cardiothorac Vasc Anesth. 2019;33:2183–91.
pubmed: 30683593
doi: 10.1053/j.jvca.2018.12.015
Xie H, Lu F, Liu W, Wang E, Wang L, Zhong M. Remimazolam alleviates neuropathic pain via regulating bradykinin receptor B1 and autophagy. J Pharm Pharmacol. 2021;73:1643–51.
pubmed: 34061162
doi: 10.1093/jpp/rgab080
Jiang J, Jiao Y, Gao P, Yin W, Zhou W, Zhang Y, et al. Propofol differentially induces unconsciousness and respiratory depression through distinct interactions between GABAA receptor and GABAergic neuron in corresponding nuclei. Acta Biochim Biophys Sin. 2021;53:1076–87.
pubmed: 34137445
doi: 10.1093/abbs/gmab084
Guan X, Jiao Z, Gong X, Cao H, Liu S, Lan H, et al. Efficacy of pre-treatment with remimazolam on prevention of propofol-induced injection pain in patients undergoing abortion or curettage: a prospective, double-blinded, randomized and placebo-controlled clinical trial. Drug Des Devel Ther. 2021;15:4551–8.
pubmed: 34764637
pmcid: 8576108
doi: 10.2147/DDDT.S334100
Bakhtiari E, Mousavi SH, Gharavi Fard M. Pharmacological control of pain during propofol injection: a systematic review and meta-analysis. Expert Rev Clin Pharmacol. 2021;14:889–99.
pubmed: 33896305
doi: 10.1080/17512433.2021.1919084
Ji L, Sun W, Lan Y, Xia C, Yu G, Wu Q, et al. Dexmedetomidine for prevention of propofol injection pain upon induction of anesthesia: a meta-analysis. Eur J Clin Pharmacol. 2020;76:1103–10.
pubmed: 32385544
doi: 10.1007/s00228-020-02889-x
Euasobhon P, Dej-arkom S, Siriussawakul A, Muangman S, Sriraj W, Pattanittum P, et al. Lidocaine for reducing propofol-induced pain on induction of anaesthesia in adults. Cochrane Database Syst Rev. 2016;2:CD007874.
pubmed: 26888026
Jalota L, Kalira V, George E, Shi Y-Y, Hornuss C, Radke O, et al. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011;342:d1110.
pubmed: 21406529
doi: 10.1136/bmj.d1110
Maraş G, Bulut H. Prevalence of nausea-vomiting and coping strategies in patients undergoing outpatient surgery. J Perianesth Nurs. 2021;36:487–91.
pubmed: 34167895
doi: 10.1016/j.jopan.2020.10.004
Ahn EJ, Kang H, Choi GJ, Baek CW, Jung YH, Woo YC. The effectiveness of Midazolam for preventing postoperative nausea and vomiting. Anesth Analg. 2016;122:664–76.
pubmed: 26516802
doi: 10.1213/ANE.0000000000001062
Lu Z, Zheng H, Chen Z, Xu S, Chen S, Mi W, et al. Effect of etomidate vs propofol for total intravenous anesthesia on major postoperative complications in older patients: a randomized clinical trial. JAMA Surg. 2022;157:888–95.
pubmed: 35947398
pmcid: 9366659
doi: 10.1001/jamasurg.2022.3338
Kutlu Yalcin E, Kim D, Mao G, Rivas E, Markwei M, Chahar P, et al. Effect of intraoperative subhypnotic infusion of propofol on postoperative nausea and vomiting: a retrospective analysis. J Clin Anesth. 2022;78:110672.
pubmed: 35151144
doi: 10.1016/j.jclinane.2022.110672
Grant MC, Kim J, Page AJ, Hobson D, Wick E, Wu CL. The effect of intravenous midazolam on postoperative nausea and vomiting. Anesth Analg. 2016;122:656–63.
pubmed: 26332858
doi: 10.1213/ANE.0000000000000941
Shirozu K, Nobukuni K, Tsumura S, Imura K, Nakashima K, Takamori S, et al. Neurological sedative indicators during general anesthesia with remimazolam. J Anesth. 2022;36:194–200.
pubmed: 34999964
doi: 10.1007/s00540-021-03030-7
Sneyd JR. Remimazolam – current status, opportunities and challenges. Anesthesiol Perioper Sci. 2023;1:25.
doi: 10.1007/s44254-023-00021-7
Schippers F, Pesic M, Saunders R, Borkett K, Searle S, Webster L, et al. Randomized crossover trial to compare abuse liability of intravenous remimazolam versus intravenous midazolam and placebo in recreational central nervous system depressant users. J Clin Pharmacol. 2020;60:1189–97.
pubmed: 32495449
pmcid: 7496124
doi: 10.1002/jcph.1614
Yang M, Zhang Y. Propofol addiction: the mechanism issues we need to know. Anesthesiol Perioper Sci. 2024;2:6.
doi: 10.1007/s44254-023-00046-y