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艾司氯胺酮对全身麻醉下胸腔镜肺手术后急性和慢性疼痛的影响:一项多中心前瞻性随机双盲对照试验。

Effects of Esketamine on Acute and Chronic Pain After Thoracoscopy Pulmonary Surgery Under General Anesthesia: A Multicenter-Prospective, Randomized, Double-Blind, and Controlled Trial.

作者信息

Lei Yishan, Liu Huayue, Xia Fan, Gan Shulin, Wang Yulan, Huo Wenwen, Wang Qinyun, Ji Fuhai

机构信息

Department of Anesthesiology, The First Affiliated Hospital of Soochow University, Suzhou, China.

出版信息

Front Med (Lausanne). 2021 Sep 8;8:693594. doi: 10.3389/fmed.2021.693594. eCollection 2021.

Abstract

Post-operative pain management for patients undergoing thoracoscopy surgery is challenging for clinicians which increase both health and economic burden. The non-selective NMDA receptor antagonist esketamine possesses an analgesic effect twice that of ketamine. The application of esketamine might be beneficial in alleviating acute and chronic pain after thoracic surgery. The current study describes the protocol aiming to evaluate the analgesic effect of esketamine after pulmonary surgery via visual analog scale (VAS) score for acute and chronic pain. A multi-center, prospective, randomized, controlled, double-blind study is designed to explore the analgesic effect of esketamine in randomized patients undergoing video-assisted thoracoscopic surgery (VATS) with general anesthesia. Patients will be randomly assigned to Esketamine Group (Group K) and Control Group (Group C) in a ratio of 1:1. Group K patients will receive esketamine with a bolus of 0.1 mg/kg after anesthesia induction, 0.1 mg/kg/h throughout the operation and 0.015 mg/kg/h in PCIA after surgery while Group C patients will receive the same volume of normal saline. The primary outcome is to measure the pain intensity through the VAS score at 3 months after the operation. The secondary outcome includes VAS score at 1, 4, 8, 24, and 48 h and on the 7th day and 1 month after the operation, complications, ketamine-related neurological side effects, recovery time of bowel function, and total amount of supplemental analgesics. The results of the current study might illustrate the analgesic effect of esketamine for patients undergoing thoracoscopy pulmonary surgery and provide evidence and insight for perioperative pain management. The trial was registered with Chinese Clinical Trial Registry (CHICTR) on Nov 18th, 2020 (ChiCTR2000040012).

摘要

对于接受胸腔镜手术的患者,术后疼痛管理对临床医生而言具有挑战性,这增加了健康和经济负担。非选择性N-甲基-D-天冬氨酸(NMDA)受体拮抗剂艾司氯胺酮的镇痛效果是氯胺酮的两倍。艾司氯胺酮的应用可能有助于减轻胸外科手术后的急性和慢性疼痛。本研究描述了旨在通过视觉模拟量表(VAS)评分评估艾司氯胺酮对肺手术后急性和慢性疼痛镇痛效果的方案。一项多中心、前瞻性、随机、对照、双盲研究旨在探讨艾司氯胺酮对接受全身麻醉的电视辅助胸腔镜手术(VATS)患者的镇痛效果。患者将按1:1的比例随机分为艾司氯胺酮组(K组)和对照组(C组)。K组患者在麻醉诱导后接受0.1mg/kg的艾司氯胺酮推注,术中持续输注0.1mg/kg/h,术后在静脉自控镇痛(PCIA)中输注0.015mg/kg/h,而C组患者将接受相同体积的生理盐水。主要结局是在术后3个月通过VAS评分测量疼痛强度。次要结局包括术后1、4、8、24和48小时以及第7天和1个月时的VAS评分、并发症、氯胺酮相关的神经副作用、肠功能恢复时间以及补充镇痛药的总量。本研究结果可能阐明艾司氯胺酮对接受胸腔镜肺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。该试验于2020年11月18日在中国临床试验注册中心(CHICTR)注册(ChiCTR2000040012)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/002a/8455819/7c48ae376e95/fmed-08-693594-g0001.jpg

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