Guo Yongle, Chen Lina, Gao Zhongquan, Zhang Min, Liu Mengjie, Gao Xiaojun, Liu Yang, Zhang Xiaoning, Guo Na, Sun Yongtao, Wang Yuelan
Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Institute of Anesthesia and Respiratory Critical Medicine, Jinan, China.
Department of Anesthesiology, Shandong First Medical University, Jinan, China.
Front Med (Lausanne). 2022 Nov 15;9:1039042. doi: 10.3389/fmed.2022.1039042. eCollection 2022.
Opioid-free anesthesia (OFA) can certainly prevent nausea and vomiting after bariatric surgery (BS), but its postoperative analgesic effect is still controversial. Obstructive sleep apnea (OSA) is a prominent feature of morbid obesity in BS and accounts for a very high proportion, which significantly increases the difficulty of patients' airway management. Those patients will be more representative and highlight the advantages of OFA. It is not clear whether esketamine can play a more prominent role in OFA for postoperative analgesia. Therefore, this study aims to explore the postoperative analgesic effect of esketamine-based OFA on BS patients with OSA.
This single-center, prospective, randomized, controlled, single-blind study is planned to recruit 48 participants to undergo BS from May 2022 to April 2023. Patients will be randomly assigned to the OFA group and opioid-based anesthesia (OBA) group in a ratio of 1:1. The primary outcome is the Numeric Rating Scale (NRS) at different times postoperatively. Secondary outcomes include analgesic intake, the incidence and severity of postoperative nausea and vomiting (PONV), Leiden Surgical Rating Scale (L-SRS), postoperative agitation and chills, PACU stay time, EuroQol five-dimensional questionnaire (EQ-5D), length of hospital stay, intraoperative awareness, and hemodynamically unstable treatments.
The results of this study may explain the analgesic effect of esketamine-based OFA on patients undergoing BS combined with OSA, and provide evidence and insight for perioperative pain management.
This study is initiated by the Ethics Committee of The First Affiliated Hospital of Shandong First Medical University [YXLL-KY-2022(035)]. The trial results will be published in peer-reviewed journals and at conferences.
[https://clinicaltrials.gov/ct2/show/NCT05386979], identifier [NCT05386979].
非阿片类麻醉（OFA）确实可以预防减重手术后的恶心和呕吐，但其术后镇痛效果仍存在争议。阻塞性睡眠呼吸暂停（OSA）是减重手术中病态肥胖的一个突出特征，占比非常高，这显著增加了患者气道管理的难度。这些患者将更具代表性，并突出OFA的优势。目前尚不清楚艾司氯胺酮在基于OFA的术后镇痛中是否能发挥更突出的作用。因此，本研究旨在探讨基于艾司氯胺酮的OFA对合并OSA的减重手术患者的术后镇痛效果。
本单中心、前瞻性、随机、对照、单盲研究计划从2022年5月至2023年4月招募48名接受减重手术的参与者。患者将按1:1的比例随机分配至OFA组和基于阿片类药物的麻醉（OBA）组。主要结局是术后不同时间的数字评定量表（NRS）。次要结局包括镇痛药物摄入量、术后恶心和呕吐（PONV）的发生率和严重程度、莱顿手术评定量表（L-SRS）、术后躁动和寒战、麻醉后恢复室（PACU）停留时间、欧洲五维健康量表（EQ-5D）、住院时间、术中知晓情况以及血流动力学不稳定的治疗情况。
本研究结果可能解释基于艾司氯胺酮的OFA对合并OSA的减重手术患者的镇痛效果，并为围手术期疼痛管理提供证据和见解。
本研究由山东第一医科大学第一附属医院伦理委员会发起[YXLL-KY-2022(035)]。试验结果将发表在同行评审期刊和会议上。
[https://clinicaltrials.gov/ct2/show/NCT05386979]，标识符[NCT05386979]。
