Cheng Shi, Wu Haixuan, Liu Zhongqi, Liu Dan, Cao Minghui, Fu Ganglan
Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Ann Med. 2025 Dec;57(1):2517820. doi: 10.1080/07853890.2025.2517820. Epub 2025 Jun 18.
Propofol is the preferred sedative for painless hysteroscopy and other procedures due to its fast onset and short duration. However, its limitations, including injection pain, respiratory depression, blood pressure decline, and bradycardia, cannot be disregarded. Ciprofol, a new short-acting gamma-aminobutyric acid receptor agonist, has shown effectiveness and safety in painless gastrointestinal endoscopy. This study aims to demonstrate that ciprofol is not inferior to propofol in terms of sedation efficacy for painless hysteroscopy.
A randomized study was conducted with 124 women to evaluate the anesthetic effect of ciprofol during outpatient painless hysteroscopy. The primary outcome assessed was the success rate of hysteroscopy, while secondary indicators included induction and recovery time, injection pain, tidal volume and respiratory rate. Safety indicators comprised hypotension, hypoxemia, and sinus bradycardia.
A total of 124 patients were enrolled in the study, with 62 in each group. The success rate of hysteroscopy was 100% in both groups. Patients in the ciprofol group had higher diastolic pressure, pulse oxygen saturation levels and minute breathing during surgery than patients in the propofol group, but their induction time and recovery time were longer. The proportion of patients in the propofol group who reported pain during intravenous anesthesia was 41.935%, which was significantly higher than that of patients in the ciprofol group (1.613%).
During painless hysteroscopy, ciprofol demonstrates non-inferiority to propofol in terms of anesthetic efficacy. Despite slightly longer induction and recovery times, ciprofol results in lower instances of injection pain and less impact on respiration and circulation compared to propofol.
Clinical trial Registration Identifier: NCT06172140.
丙泊酚因其起效快、作用时间短，是无痛宫腔镜检查及其他手术首选的镇静剂。然而，其局限性，包括注射痛、呼吸抑制、血压下降和心动过缓，不容忽视。环泊酚是一种新型短效γ-氨基丁酸受体激动剂，已在无痛胃肠内镜检查中显示出有效性和安全性。本研究旨在证明在无痛宫腔镜检查的镇静效果方面，环泊酚不劣于丙泊酚。
对124名女性进行了一项随机研究，以评估环泊酚在门诊无痛宫腔镜检查中的麻醉效果。评估的主要结局是宫腔镜检查的成功率，次要指标包括诱导和恢复时间、注射痛、潮气量和呼吸频率。安全指标包括低血压、低氧血症和窦性心动过缓。
本研究共纳入124例患者，每组62例。两组宫腔镜检查成功率均为100%。环泊酚组患者术中舒张压、脉搏血氧饱和度水平和分钟通气量均高于丙泊酚组，但诱导时间和恢复时间较长。丙泊酚组静脉麻醉期间报告疼痛的患者比例为41.935%，显著高于环泊酚组（1.613%）。
在无痛宫腔镜检查中，环泊酚在麻醉效果方面不劣于丙泊酚。尽管诱导和恢复时间略长，但与丙泊酚相比，环泊酚导致的注射痛发生率更低，对呼吸和循环的影响更小。
临床试验注册标识符：NCT06172140。
