Sun Qirong, Luo Jiao, Zhang Shijia, Zhou Leng
Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
Trials. 2024 Dec 4;25(1):810. doi: 10.1186/s13063-024-08600-0.
The utilization of shoulder arthroscopic surgery has progressively increased as a prevalent surgical approach for the treatment and repair of rotator cuff injury in clinical practice. However, early postoperative pain and neurological dysfunction remain significant factors that impact patients' postoperative recovery. Esketamine, an NMDA receptor antagonist, effectively reduces opioid consumption, attenuates postoperative inflammatory reactivity, and has also demonstrated neuroprotective effects. The aim of this study is to evaluate the quality of early recovery after anesthesia maintenance with esketamine in patients undergoing arthroscopic rotator cuff repair.
This is a single-center, randomized controlled trial. A total of 234 patients undergoing arthroscopic rotator cuff repair will be enrolled and randomized at a 1:1:1 ratio to receive general anesthesia with different doses of esketamine or saline solution. The primary outcome is the quality of early recovery scores based on the QoR-15 scale on postoperative day 1. Secondary outcomes include the quality of early recovery scores based on the QoR-15 scale on postoperative day 3, remifentanil consumption, use of vasoactive drugs, cerebral desaturation events, rescue analgesia during the post-anesthesia care unit stay, NRS pain scores on postoperative days 1 and 2, delirium within 3 days after surgery, and adverse events.
A randomized controlled trial design will be used in this study to assess the quality of early recovery scores in patients undergoing arthroscopic rotator cuff repair. Our objective is to investigate the potential of esketamine in mitigating the adverse effects associated with intraoperative controlled hypotension and assessing its impact on intraoperative cerebral oxygen saturation and postoperative delirium. Although this study is conducted at a single center, and there is limited research on the long-term effects of perioperative esketamine on patients, it still offers valuable insights for future studies.
This study has been approved by the Ethics Committee at West China Hospital, Sichuan University (approval no. 2023-2282). Trial registration number ChiCTR2400080589. Registered on 2024.02.01.
在临床实践中，肩关节镜手术作为治疗和修复肩袖损伤的一种常用手术方法，其应用率逐渐增加。然而，术后早期疼痛和神经功能障碍仍然是影响患者术后恢复的重要因素。艾司氯胺酮是一种N-甲基-D-天冬氨酸（NMDA）受体拮抗剂，可有效减少阿片类药物的使用，减轻术后炎症反应，还具有神经保护作用。本研究的目的是评估在接受关节镜下肩袖修复术的患者中，使用艾司氯胺酮维持麻醉后早期恢复的质量。
这是一项单中心随机对照试验。总共234例接受关节镜下肩袖修复术的患者将按1:1:1的比例入组并随机分组，分别接受不同剂量的艾司氯胺酮或生理盐水溶液全身麻醉。主要结局是术后第1天基于QoR-15量表的早期恢复质量评分。次要结局包括术后第3天基于QoR-15量表的早期恢复质量评分、瑞芬太尼用量、血管活性药物的使用、脑氧饱和度降低事件、麻醉后监护病房停留期间的补救镇痛、术后第1天和第2天的数字疼痛评分量表（NRS）疼痛评分、术后3天内的谵妄以及不良事件。
本研究将采用随机对照试验设计来评估接受关节镜下肩袖修复术患者的早期恢复质量评分。我们的目的是研究艾司氯胺酮减轻与术中控制性低血压相关不良反应的潜力，并评估其对术中脑氧饱和度和术后谵妄的影响。尽管本研究在单中心进行，且关于围手术期艾司氯胺酮对患者长期影响的研究有限，但它仍为未来的研究提供了有价值的见解。
本研究已获得四川大学华西医院伦理委员会批准（批准号2023-2282）。试验注册号ChiCTR2400080589。于2024年2月1日注册。
