Department of Anaesthesiology, Shidong Hospital of Shanghai, University of Shanghai for Science and Technology, Shiguang Rd., No. 999, Shanghai, China.
Department of Anaesthesiology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Changhai Rd., No.225, Shanghai, China.
Trials. 2023 Jan 6;24(1):13. doi: 10.1186/s13063-022-07003-3.
Although opioids are commonly prescribed in clinical anaesthesia, the significant side effects attributed to their overuse are raising increasing concerns. One way to reduce perioperative opioid consumption is to apply opioid-reduced anaesthesia (ORA) and even opioid-free anaesthesia (OFA), which involves regional techniques, neuraxial anaesthesia, nonopioid analgesics or combined use. The aim of this study was to investigate whether the application of OFA by using esketamine in intraoperative analgesia could minimize the side effects of postoperative nausea and vomiting (PONV), as well as other short-term side effects related to anaesthesia.
METHODS/DESIGN: The study was designed as a prospective, randomized, controlled, multicentre trial. A total of 278 patients were enrolled; participants were nonsmoking female patients aged 18-50 years and scheduled for laparoscopic appendectomy or cholecystectomy, ASA at I-III, with no serious physical or mental diseases. Both groups received usual perioperative care except for the analgesic medication of either esketamine or sufentanil. The primary outcome was the incidence of PONV 3 days after surgery. Secondary outcomes included recovery status, pain, sedation level and overall recovery, delirium and cognition, anxiety and depression and total consumption of analgesic agents.
This trial may show that the synergy of esketamine and propofol anaesthesia reduces PONV as well as other short-term adverse events, thereby providing a better safety and satisfaction profile of ERAS for laparoscopic appendectomy and cholecystectomy.
Chinese Clinical Trial Registry ChiCTR2100047169. Registered on June 9, 2021.
尽管阿片类药物在临床麻醉中经常被开处，但由于其过度使用而产生的显著副作用引起了越来越多的关注。减少围手术期阿片类药物消耗的一种方法是应用阿片类药物减少麻醉（ORA）甚至无阿片类药物麻醉（OFA），包括区域技术、椎管内麻醉、非阿片类镇痛药或联合使用。本研究旨在探讨术中镇痛中使用氯胺酮应用 OFA 是否可以最大限度地减少术后恶心和呕吐（PONV）以及与麻醉相关的其他短期副作用。
方法/设计：该研究设计为前瞻性、随机、对照、多中心试验。共纳入 278 例患者；参与者为年龄 18-50 岁的非吸烟女性患者，拟行腹腔镜阑尾切除术或胆囊切除术，ASA 分级 I-III，无严重的身体或精神疾病。两组均接受常规围手术期护理，除接受氯胺酮或舒芬太尼镇痛药物外。主要结局是术后 3 天 PONV 的发生率。次要结局包括恢复状态、疼痛、镇静水平和整体恢复、谵妄和认知、焦虑和抑郁以及镇痛药总消耗量。
本试验可能表明氯胺酮和丙泊酚麻醉的协同作用可降低 PONV 以及其他短期不良事件，从而为腹腔镜阑尾切除术和胆囊切除术提供更好的加速康复外科安全和满意度。
中国临床试验注册中心 ChiCTR2100047169。于 2021 年 6 月 9 日注册。
