Department of Anesthesiology and Pain Medicine, Wonju College of Medicine, Yonsei University, Ilsan-ro 20, Wonju-si, Gangwon-do, 26426, Republic of Korea.
Department of Anesthesiology and Pain Medicine, Wonju Severance Christian Hospital, Wonju-si, Republic of Korea.
BMC Anesthesiol. 2022 Jul 16;22(1):226. doi: 10.1186/s12871-022-01770-x.
Remimazolam is a novel intravenous benzodiazepine that is appropriate for the maintenance of anesthesia. Quality of recovery is an important component of health care quality, but there is no published randomized control trial focused on the quality of recovery in patients undergoing total intravenous anesthesia with remimazolam.
This parallel-group, single-blind randomized control trial at a tertiary care medical center in South Korea was conducted to determine the difference in the quality of recovery between the patients administered remimazolam and those administered an inhalant anesthetic agent. A total of 168 patients aged 19-65 years who underwent elective laparoscopic cholecystectomy or robotic gynecologic surgery were considered for enrollment. Randomization was performed using sealed envelopes containing computer-generated random allocation sequences. Remimazolam was administered for the maintenance of anesthesia in the remimazolam group (Group R), and desflurane was administered in the desflurane group (Group D). The induction protocol and the target value of the bispectral index were identical in both groups. Patients were blinded to the drug that was administered until they finished the postoperative questionnaire. The main outcome measure was the decrement of the QoR-40 score on postoperative day 1 compared to the QoR-40 score on the day before surgery.
A total of 165 patients were analyzed. The preoperative and postoperative global QoR-40 scores were 183 and 152 (IQR 173-192 and 136-169), respectively. The perioperative decrement of the global QoR-40 score was 29.96 ± 22.49. The decrement of the QoR-40 score was smaller in Group R than in Group D (26.99 versus 32.90, respectively; mean difference 5.91, 95% confidence interval -0.96-12.79). After adjustment for sex, the type of surgery and surgical time, the administration of remimazolam resulted in a 7.03-point (95% CI 0.35-13.72) less decrement of the QoR-40 score than desflurane. There were no severe adverse events in either group.
Total intravenous anesthesia maintained with remimazolam provides a better quality of recovery than anesthesia maintained with an inhalant agent in patients undergoing laparoscopic surgery. Additionally, postoperative nausea and vomiting were largely reduced with remimazolam.
KCT0006288 , Clinical Research Information Service (CRIS), Republic of Korea Registration date: 23/06/2021.
雷米唑仑是一种新型的静脉用苯二氮䓬类药物，适用于维持麻醉。恢复质量是医疗保健质量的一个重要组成部分，但目前还没有发表专门针对雷米唑仑全静脉麻醉患者恢复质量的随机对照试验。
这是一项在韩国一家三级医疗中心进行的平行组、单盲随机对照试验，旨在确定接受雷米唑仑和吸入麻醉剂维持麻醉的患者在恢复质量方面的差异。共有 168 名年龄在 19-65 岁之间的患者被纳入接受择期腹腔镜胆囊切除术或机器人妇科手术的研究。使用包含计算机生成的随机分配序列的密封信封进行随机分组。雷米唑仑组（R 组）给予雷米唑仑维持麻醉，地氟醚组（D 组）给予地氟醚维持麻醉。两组的诱导方案和脑电双频指数的目标值相同。患者在完成术后问卷调查前对所给予的药物保持盲态。主要观察指标为与术前相比，术后第 1 天 QoR-40 评分的下降。
共有 165 名患者纳入分析。术前和术后的全球 QoR-40 评分分别为 183 和 152（IQR 173-192 和 136-169）。全球 QoR-40 评分的围手术期下降幅度为 29.96±22.49。R 组的 QoR-40 评分下降幅度小于 D 组（分别为 26.99 与 32.90，平均差异 5.91，95%置信区间-0.96-12.79）。在校正性别、手术类型和手术时间后，与地氟醚相比，雷米唑仑维持的全静脉麻醉导致 QoR-40 评分下降减少 7.03 分（95%置信区间 0.35-13.72）。两组均无严重不良事件。
在接受腹腔镜手术的患者中，与吸入麻醉剂维持的麻醉相比，用雷米唑仑维持的全静脉麻醉可提供更好的恢复质量。此外，雷米唑仑可显著减少术后恶心和呕吐。
KCT0006288，临床研究信息服务（CRIS），韩国，注册日期：2021 年 6 月 23 日。
