Tang Jinxuan, Chen Fang, Huang Jiayu, Li Dongliang, Li Cheng
Department of Anesthesiology and Perioperative medicine, Shanghai Key Laboratory of Anesthesiology and Brain Functional Modulation, Clinical Research Center for Anesthesiology and Perioperative Medicine, Translational Research Institute of Brain and Brain-Like Intelligence, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, People's Republic of China.
Department of Anesthesiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, People's Republic of China.
BMJ Open. 2025 Jan 22;15(1):e083068. doi: 10.1136/bmjopen-2023-083068.
Propofol is a fast-acting intravenous anaesthetic widely used for sedation and anaesthesia in gastrointestinal endoscopy, bronchoscopy, and the induction/maintenance of general anaesthesia in outpatients and inpatients; however, propofol has several undesirable effects, including injection pain, which affects the physical and mental health of patients, and cardiopulmonary depression, characterised by hypotension, bradycardia and apnea, which commonly occur in clinical practice. Ciprofol (HSK3486) is a propofol analogue with good clinical safety, high potency and some advantages over propofol, including lower injection pain and haemodynamic depression in patients undergoing gastroscopy and colonoscopy. This study aims to compare the impact of equivalent effective doses of propofol and ciprofol on haemodynamic changes in patients undergoing bronchoscopy under general anaesthesia.
This prospective, double-blind, randomised, controlled clinical trial will recruit 250 patients aged 18-80 years scheduled for elective bronchoscopy under general anaesthesia. The cohort will be randomised into two groups in a 1:1 ratio: propofol (200 mg/20 mL of saline) and ciprofol (40 mg/20 mL of saline). The primary outcomes are changes in heart rate and blood pressure before and after induction, laryngeal mask airway (LMA) placement and bronchoscopy placement. The secondary outcomes are the incidence of choking and injection pain, the type and dose of vasoactive drugs used during the operation, and the level of postoperative satisfaction among surgeons, anaesthesiologists and patients.
This trial was approved by the Medical Ethics Committee of Shanghai Fourth People's Hospital, School of Medicine, Tongji University and registered with the Chinese Clinical Trials Registry (Identifier: ChiCTR2200063048) on 29 August 2022. The findings of this study will be disseminated through various channels. Academic dissemination will include publication in peer-reviewed journals and presentations at national and international conferences.
ChiCTR2200063048.
丙泊酚是一种起效迅速的静脉麻醉药，广泛用于胃肠内镜检查、支气管镜检查中的镇静和麻醉，以及门诊和住院患者全身麻醉的诱导/维持；然而，丙泊酚有几种不良影响，包括注射痛，这会影响患者的身心健康，以及心肺抑制，其特征为低血压、心动过缓和呼吸暂停，在临床实践中较为常见。环泊酚（HSK3486）是一种丙泊酚类似物，具有良好的临床安全性、高效性，且相较于丙泊酚有一些优势，包括在接受胃镜和结肠镜检查的患者中注射痛较轻以及血流动力学抑制较轻。本研究旨在比较等效有效剂量的丙泊酚和环泊酚对全身麻醉下接受支气管镜检查患者血流动力学变化的影响。
这项前瞻性、双盲、随机、对照临床试验将招募250名年龄在18至80岁之间计划接受全身麻醉下择期支气管镜检查的患者。该队列将按1:1的比例随机分为两组：丙泊酚组（200毫克/20毫升生理盐水）和环泊酚组（40毫克/20毫升生理盐水）。主要结局是诱导前、置入喉罩气道（LMA）和置入支气管镜前后心率和血压的变化。次要结局是呛咳和注射痛的发生率、手术期间使用的血管活性药物的类型和剂量，以及外科医生、麻醉医生和患者的术后满意度水平。
本试验已获得同济大学医学院附属上海市第四人民医院医学伦理委员会的批准，并于2022年8月29日在中国临床试验注册中心注册（标识符：ChiCTR2200063048）。本研究的结果将通过各种渠道传播。学术传播将包括在同行评审期刊上发表以及在国内和国际会议上进行报告。
ChiCTR2200063048。
