Yu Youjia, Ma Qingfang, Du Fengxia, Zhang Xiang, Shao Chunyan, Li Yan, Ma Chuntao
Department of Pain and Anesthesiology, Suzhou Xiangcheng People's Hospital, Suzhou, China.
Department of Gastroenterology and Endoscopy Center, Suzhou Xiangcheng People's Hospital, Suzhou, China.
Front Pharmacol. 2025 May 30;16:1599684. doi: 10.3389/fphar.2025.1599684. eCollection 2025.
In recent years, the rapid increase in gastrointestinal endoscopic procedures has posed new demands and challenges for painless and comfortable medical care. Intravenous anesthetics may increase postoperative euphoria in patients. This study aims to evaluate the effects of intravenous propofol combined with fentanyl, nalbuphine, or saline on euphoria in patients undergoing painless gastrointestinal endoscopy.
This is a single-center, randomized, double-blind, placebo-controlled trial protocol involving 285 adult patients scheduled for bidirectional endoscopy. Participants will be randomly assigned to either the fentanyl group, the nalbuphine group, or the placebo group (n = 95 per group). The fentanyl group will receive propofol + fentanyl; the nalbuphine group will receive propofol + nalbuphine; and the placebo group will receive propofol + saline. The primary outcome is the Addiction Research Center Inventory (ARCI) - Morphine-Benzedrine Group (MBG) scores at 30 min post-awakening. Secondary outcomes will include ARCI-MBG scores at 1 week and 1 month postoperatively; ARCI total scores at 30 min post-awakening, 1 week, and 1 month postoperatively; ARCI-Pentobarbital, Chlorpromazine, Alcohol Group (PCAG) scores at 30 min post-awakening, 1 week, and 1 month postoperatively; ARCI-Lysergic Acid Diethylamide (LSD) scores at 30 min post-awakening, 1 week, and 1 month postoperatively; Pittsburgh Sleep Quality Index scores at 1 week and 1 month postoperatively; and dream descriptions (none, pleasant, or nightmare) at 30 min post-awakening; The Surgical Pleth Index assessed at the time of endoscope insertion. Safety outcomes will include desaturation, hypotension, nausea or vomiting, dizziness, headache, choking cough, involuntary movement, bradycardia, and airway intervention. Data will be analyzed following a modified intention-to-treat approach.
This study aims to provide high-quality evidence for the potential addictive properties and safety of propofol combined with opioids in gastrointestinal endoscopy procedures.
This study was approved by the Ethics Committee of Xiangcheng People's Hospital of Suzhou (2024-KY-05) on 19 August 2024, and is registered with the Chinese Clinical Trial Registry (ChiCTR2500096595). All participants will provide written informed consent, and the study will adhere to the principles of the Declaration of Helsinki. The findings will be published in a peer-reviewed journal. URL: https://www.chictr.org.cn/showproj.html?proj=252367.
近年来，胃肠道内镜检查程序的迅速增加对无痛舒适医疗提出了新的要求和挑战。静脉麻醉剂可能会增加患者术后的欣快感。本研究旨在评估静脉注射丙泊酚联合芬太尼、纳布啡或生理盐水对接受无痛胃肠道内镜检查患者欣快感的影响。
这是一项单中心、随机、双盲、安慰剂对照试验方案，涉及285名计划进行双向内镜检查的成年患者。参与者将被随机分配到芬太尼组、纳布啡组或安慰剂组（每组n = 95）。芬太尼组将接受丙泊酚 + 芬太尼；纳布啡组将接受丙泊酚 + 纳布啡；安慰剂组将接受丙泊酚 + 生理盐水。主要结局是苏醒后30分钟的成瘾研究中心量表（ARCI）-吗啡-苯丙胺组（MBG）评分。次要结局将包括术后1周和1个月时的ARCI-MBG评分；术后苏醒后30分钟、1周和1个月时的ARCI总分；术后苏醒后30分钟、1周和1个月时的ARCI-戊巴比妥、氯丙嗪、酒精组（PCAG）评分；术后苏醒后30分钟、1周和1个月时的ARCI-麦角酸二乙酰胺（LSD）评分；术后1周和1个月时的匹兹堡睡眠质量指数评分；以及苏醒后30分钟的梦境描述（无、愉快或噩梦）；在内镜插入时评估的手术脉搏指数。安全性结局将包括血氧饱和度降低、低血压、恶心或呕吐、头晕、头痛、呛咳、不自主运动、心动过缓和气道干预。数据将采用改良的意向性分析方法进行分析。
本研究旨在为丙泊酚联合阿片类药物在胃肠道内镜检查程序中的潜在成瘾性和安全性提供高质量证据。
本研究于2024年8月19日获得苏州相城人民医院伦理委员会批准（2024-KY-05），并在中国临床试验注册中心注册（ChiCTR2500096595）。所有参与者将提供书面知情同意书，本研究将遵循《赫尔辛基宣言》的原则。研究结果将发表在同行评审期刊上。网址：https://www.chictr.org.cn/showproj.html?proj=252367。
