Department of Obstetrics and Gynecology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul, 137-701, Republic of Korea.
Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul, 137-701, Republic of Korea.
Trials. 2021 Mar 12;22(1):207. doi: 10.1186/s13063-021-05166-z.
Because of the indiscriminate use of opioids during the perioperative period, opioid-free anesthesia (OFA) has been increasingly required. Nevertheless, the studies on the detailed techniques and effects of OFA are not sufficient. The Quality of Recovery-40 (QoR-40) questionnaire is a validated assessment tool for measuring recovery from general anesthesia. However, no study has used the QoR-40 to determine if OFA leads to better recovery than standard general anesthesia. Therefore, we aim to perform this study to determine the effects of OFA using dexmedetomidine and lidocaine on the quality of recovery as well as the various postoperative outcomes.
The participants (n = 78) will be allocated to one of the two groups; the study group will receive bolus and infusion of dexmedetomidine and lidocaine, and the control group will receive remifentanil infusion during general anesthesia for gynecological laparoscopy. The other processes including anesthetic and postoperative care will be performed similarly in the two groups. Intraoperative hemodynamic, anesthetic, and nociceptive variables will be recorded. Postoperative outcomes such as QoR-40, pain severity, and opioid-related side effects will be assessed. Additionally, an ancillary cytokine study (inflammatory cytokine, stress hormone, and reactive oxygen species) will be performed during the study period.
This will be the first study to determine the effect of OFA, using the combination of dexmedetomidine and lidocaine, on the quality of recovery after gynecological laparoscopy compared with standard general anesthesia using remifentanil. The findings from this study will provide scientific and clinical evidence on the efficacy of OFA.
ClinicalTrials.gov NCT04409964 . Registered on 28 May 2020.
由于围手术期阿片类药物的滥用，越来越需要无阿片类麻醉（OFA）。然而，关于 OFA 的详细技术和效果的研究还不够充分。恢复质量-40（QoR-40）问卷是一种经过验证的评估工具，用于衡量全身麻醉后的恢复情况。然而，尚无研究使用 QoR-40 来确定 OFA 是否比标准全身麻醉导致更好的恢复。因此，我们旨在进行这项研究，以确定使用右美托咪定和利多卡因的 OFA 对恢复质量以及各种术后结果的影响。
将参与者（n=78）分配到两组之一；研究组将接受右美托咪定和利多卡因的推注和输注，对照组将在妇科腹腔镜手术期间接受瑞芬太尼输注进行全身麻醉。两组的其他过程包括麻醉和术后护理将类似进行。术中记录血流动力学、麻醉和伤害性变量。评估术后结果，如 QoR-40、疼痛严重程度和阿片类药物相关副作用。此外，在研究期间还将进行辅助细胞因子研究（炎症细胞因子、应激激素和活性氧）。
这将是第一项研究，旨在确定使用右美托咪定和利多卡因的 OFA 对妇科腹腔镜手术后恢复质量的影响，与使用瑞芬太尼的标准全身麻醉相比。这项研究的结果将为 OFA 的疗效提供科学和临床证据。
ClinicalTrials.gov NCT04409964。于 2020 年 5 月 28 日注册。
