Comparison of the efficacy and safety of ciprofol and propofol for ERCP anesthesia in older patients: A single-center randomized controlled clinical study

IF 5 2区医学 Q1 ANESTHESIOLOGY

Journal of Clinical Anesthesia Pub Date : 2024-09-16 DOI:10.1016/j.jclinane.2024.111609

{"title":"Comparison of the efficacy and safety of ciprofol and propofol for ERCP anesthesia in older patients: A single-center randomized controlled clinical study","authors":"","doi":"10.1016/j.jclinane.2024.111609","DOIUrl":null,"url":null,"abstract":"<div><h3>Study objectives</h3><p>Ciprofol is a novel agonist at the gamma-aminobutyric acid-A (GABA<sub>A</sub>) receptor, exhibiting better cardiovascular stability and rapid recovery. The objective of this study was to compare the efficacy and safety of ciprofol and propofol for endoscopic retrograde cholangiopancreatography (ERCP) anesthesia in older patients.</p></div><div><h3>Design</h3><p>A single-center, randomized, parallel controlled clinical study.</p></div><div><h3>Setting</h3><p>General Hospital of Northern Theater Command.</p></div><div><h3>Patients</h3><p>We recruited 284 patients and intended to conduct ERCP from November 2021 to June 2022.</p></div><div><h3>Interventions</h3><p>Patients scheduled for ERCP were randomly assigned to two groups (n = 142 each): ciprofol group (anesthesia induction 0.3–0.4 mg/kg, anesthesia maintenance 0.8–1.2 mg/kg/h) and propofol group (anesthesia induction 1.5–2.0 mg/kg, anesthesia maintenance 4-12 mg/kg/h).</p></div><div><h3>Measurements</h3><p>The primary outcome was sedation success rate, defined as the proportion of patients with successful anesthesia induction. Secondary outcomes encompassed the time of successful induction, the time of complete recovery, the time of leaving the room and the incidence rate of adverse events (hypoxemia, hypotension and injection pain).</p></div><div><h3>Main results</h3><p>The success rate of sedation in both groups was 100 %. The 95 % CI of the difference of sedation success rate was (− 2.63 %, 2.63 %), and the lower limit was greater than the non-inferiority limit of −8 %.The time of successful sedation induction in ciprofol group (38.4 ± 6.5 s) was longer than that in propofol group (30.6 ± 6.2 s, <em>p</em> < 0.05).The time of complete recovery in ciprofol group (12.8 ± 5.8 min) was shorter than that in propofol group (16.9 ± 5.0 min, <em>p</em> < 0.05). The time of leaving the room in ciprofol group (21.8 ± 5.8 min) was shorter than those in propofol group (25.9 ± 5.1 min, <em>p</em> < 0.05). The incidence of injection pain in ciprofol group (2 %) was lower than that in the propofol group (25 %, <em>p</em> < 0.05). Other outcomes didn't show statistical differences.</p></div><div><h3>Conclusions</h3><p>Compared with propofol, ciprofol exhibited a comparable level of sedation in older patients undergoing ERCP, and recovery was safe and rapid with less injection pain.</p><p>Trial registration: <span><span>www.chictr.org.cn</span><svg><path></path></svg></span> (Registration number ChiCTR2100053386, Registration date November 20, 2021).</p></div>","PeriodicalId":15506,"journal":{"name":"Journal of Clinical Anesthesia","volume":null,"pages":null},"PeriodicalIF":5.0000,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0952818024002381/pdfft?md5=07e9244f3e48f9335440f009699cf2db&pid=1-s2.0-S0952818024002381-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Anesthesia","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0952818024002381","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Study objectives

Ciprofol is a novel agonist at the gamma-aminobutyric acid-A (GABA_A) receptor, exhibiting better cardiovascular stability and rapid recovery. The objective of this study was to compare the efficacy and safety of ciprofol and propofol for endoscopic retrograde cholangiopancreatography (ERCP) anesthesia in older patients.

Design

A single-center, randomized, parallel controlled clinical study.

Setting

General Hospital of Northern Theater Command.

Patients

We recruited 284 patients and intended to conduct ERCP from November 2021 to June 2022.

Interventions

Patients scheduled for ERCP were randomly assigned to two groups (n = 142 each): ciprofol group (anesthesia induction 0.3–0.4 mg/kg, anesthesia maintenance 0.8–1.2 mg/kg/h) and propofol group (anesthesia induction 1.5–2.0 mg/kg, anesthesia maintenance 4-12 mg/kg/h).

Measurements

The primary outcome was sedation success rate, defined as the proportion of patients with successful anesthesia induction. Secondary outcomes encompassed the time of successful induction, the time of complete recovery, the time of leaving the room and the incidence rate of adverse events (hypoxemia, hypotension and injection pain).

Main results

The success rate of sedation in both groups was 100 %. The 95 % CI of the difference of sedation success rate was (− 2.63 %, 2.63 %), and the lower limit was greater than the non-inferiority limit of −8 %.The time of successful sedation induction in ciprofol group (38.4 ± 6.5 s) was longer than that in propofol group (30.6 ± 6.2 s, p < 0.05).The time of complete recovery in ciprofol group (12.8 ± 5.8 min) was shorter than that in propofol group (16.9 ± 5.0 min, p < 0.05). The time of leaving the room in ciprofol group (21.8 ± 5.8 min) was shorter than those in propofol group (25.9 ± 5.1 min, p < 0.05). The incidence of injection pain in ciprofol group (2 %) was lower than that in the propofol group (25 %, p < 0.05). Other outcomes didn't show statistical differences.

Conclusions

Compared with propofol, ciprofol exhibited a comparable level of sedation in older patients undergoing ERCP, and recovery was safe and rapid with less injection pain.

Trial registration: www.chictr.org.cn (Registration number ChiCTR2100053386, Registration date November 20, 2021).

查看原文本刊更多论文

比较异丙酚和丙泊酚用于老年患者ERCP麻醉的有效性和安全性：单中心随机对照临床研究

研究目的异丙酚是γ-氨基丁酸-A（GABAA）受体的新型激动剂，具有更好的心血管稳定性和快速恢复能力。本研究旨在比较异丙酚和丙泊酚用于老年患者内镜逆行胰胆管造影术（ERCP）麻醉的有效性和安全性。干预措施计划进行ERCP的患者被随机分配到两组（每组142人）：环丙酚组（麻醉诱导0.3-0.4 mg/kg，麻醉维持0.8-1.2 mg/kg/h）和丙泊酚组（麻醉诱导1.5-2.0 mg/kg，麻醉维持4-12 mg/kg/h）。次要结果包括诱导成功时间、完全恢复时间、离开病房时间和不良事件（低氧血症、低血压和注射疼痛）的发生率。两组镇静成功率均为 100%，镇静成功率差异的 95 % CI 为（- 2.63 %，2.63 %），下限大于非劣效限 -8 %。环丙酚组完全恢复时间（12.8±5.8 min）短于丙泊酚组（16.9±5.0 min，P < 0.05）。环丙酚组离开房间的时间（21.8 ± 5.8 分钟）比异丙酚组（25.9 ± 5.1 分钟，P < 0.05）短。环丙酚组的注射疼痛发生率（2%）低于异丙酚组（25%，P < 0.05）。结论与异丙酚相比，环丙酚在老年ERCP患者中的镇静效果相当，且恢复安全迅速，注射疼痛较轻。试验注册：www.chictr.org.cn（注册号ChiCTR2100053386，注册日期2021年11月20日）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of Clinical Anesthesia 医学-麻醉学

CiteScore

7.40

自引率

4.50%

发文量

346

审稿时长

23 days

期刊介绍： The Journal of Clinical Anesthesia (JCA) addresses all aspects of anesthesia practice, including anesthetic administration, pharmacokinetics, preoperative and postoperative considerations, coexisting disease and other complicating factors, cost issues, and similar concerns anesthesiologists contend with daily. Exceptionally high standards of presentation and accuracy are maintained. The core of the journal is original contributions on subjects relevant to clinical practice, and rigorously peer-reviewed. Highly respected international experts have joined together to form the Editorial Board, sharing their years of experience and clinical expertise. Specialized section editors cover the various subspecialties within the field. To keep your practical clinical skills current, the journal bridges the gap between the laboratory and the clinical practice of anesthesiology and critical care to clarify how new insights can improve daily practice.