The efficacy and safety of ciprofol versus propofol in patients undergoing painless hysteroscopy: a randomized, double-blind, controlled trial.

IF 2.3 3区 医学 Q2 ANESTHESIOLOGY
Aijun Li, Ning Li, Lei Zhu, Zige Xu, Yifan Wang, Junjie Li, Gerong Zhang
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引用次数: 0

Abstract

Background: Studies have reported that ciprofol has the advantage of reducing injection pain compared to propofol during gastroscopy, colonoscopy, and fiberoptic bronchoscopy. The effect of ciprofol on the injection pain in painless hysteroscopy needs to further explore.

Methods: A double-blind randomized controlled trial (RCT) was designed, and patients were recruited from the First Central Hospital of Baoding from March 2024 to June 2024. The eligible participants were allocated into ciprofol group (ciprofol combined with alfentanil) and propofol group (propofol combined with alfentanil) at 1:1 ratio. The primary outcome was injection pain. The secondary outcomes included sedation success rate, anesthesia success rate, adverse events, patient satisfaction, and comparison of vital signs before and after administration.

Results: A total of 217 participants were included for analysis, with 109 participants in the ciprofol group and 108 participants in the propofol group. The injection pain rate of ciprofol group (18.35%) was significantly lower than the propofol group (40.74%). Both the ciprofol group and propofol group had 100% of the sedation success rate. The anesthesia success rate between the two groups was comparable (P > 0.05). The rate of adverse events was lower (27.52% vs. 45.37%) and patient satisfaction was higher (9.84 ± 0.45 vs. 9.65 ± 0.85) in the ciprofol group than the propofol group. In addition, values of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) in propofol group were significantly lower than those in ciprofol group at the time of cervical dilation and consciousness recovery.

Conclusions: Ciprofol exhibits comparable efficacy to that of propofol, and is associated with less injection pain rate, fewer adverse events, higher patient satisfaction, and more stable hemodynamics when used for general anesthesia during the painless hysteroscopy.

Clinical trial number: NCT06413862.

在接受无痛宫腔镜检查的患者中使用环丙酚与异丙酚的有效性和安全性:随机、双盲、对照试验。
背景:研究表明,与异丙酚相比,环丙酚在胃镜、结肠镜和纤维支气管镜检查中具有减轻注射疼痛的优势。环丙酚对无痛宫腔镜检查中注射疼痛的影响有待进一步探讨:设计了一项双盲随机对照试验(RCT),从 2024 年 3 月至 2024 年 6 月在保定市第一中心医院招募患者。符合条件的参与者按1:1的比例被分配到异丙酚组(异丙酚联合阿芬太尼)和丙泊酚组(丙泊酚联合阿芬太尼)。主要结果是注射疼痛。次要结果包括镇静成功率、麻醉成功率、不良反应、患者满意度以及用药前后生命体征的比较:共有 217 人参与分析,其中环丙酚组 109 人,异丙酚组 108 人。环丙酚组的注射疼痛率(18.35%)明显低于异丙酚组(40.74%)。环丙酚组和丙泊酚组的镇静成功率均为 100%。两组的麻醉成功率相当(P > 0.05)。与异丙酚组相比,环丙酚组的不良反应发生率更低(27.52% vs. 45.37%),患者满意度更高(9.84 ± 0.45 vs. 9.65 ± 0.85)。此外,在颈椎扩张和意识恢复时,异丙酚组的收缩压(SBP)、舒张压(DBP)和平均动脉压(MAP)值明显低于丙泊酚组:结论:在无痛宫腔镜手术中使用环丙酚进行全身麻醉时,环丙酚的疗效与异丙酚相当,注射疼痛率更低,不良反应更少,患者满意度更高,血流动力学更稳定:临床试验编号:NCT06413862。
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来源期刊
BMC Anesthesiology
BMC Anesthesiology ANESTHESIOLOGY-
CiteScore
3.50
自引率
4.50%
发文量
349
审稿时长
>12 weeks
期刊介绍: BMC Anesthesiology is an open access, peer-reviewed journal that considers articles on all aspects of anesthesiology, critical care, perioperative care and pain management, including clinical and experimental research into anesthetic mechanisms, administration and efficacy, technology and monitoring, and associated economic issues.
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