PDF(Pubmed)
Abstract：
In this randomized controlled trial, 74 patients scheduled for gynecological laparoscopic surgery (American Society of Anesthesiologists grade I/II) were enrolled and randomly divided into two study groups: (i) Group C (control), received sufentanil (0.3 μg/kg) and saline, followed by sufentanil (0.1 μg/kg∙h) and saline; and (ii) Group F (OFA), received esketamine (0.15 mg/kg) and lidocaine (2 mg/kg), followed by esketamine (0.1 mg/kg∙h) and lidocaine (1.5 mg/kg∙h). The primary outcome was the 48-h time-weighted average (TWA) of postoperative pain scores. Secondary outcomes included time to extubation, adverse effects, and postoperative sedation score, pain scores at different time points, analgesic consumption at 48 h, and gastrointestinal functional recovery. The 48-h TWAs of pain scores were 1.32 (0.78) (95% CI 1.06-1.58) and 1.09 (0.70) (95% CI 0.87-1.33) for Groups F and C, respectively. The estimated difference between Groups F and C was - 0.23 (95% CI - 0.58 - 0.12; P = 0.195). No differences were found in any of the secondary outcomes and no severe adverse effects were observed in either group. Balanced OFA with lidocaine and esketamine achieved similar effects to balanced anesthesia with sufentanil in patients undergoing elective gynecological laparoscopic surgery, without severe adverse effects.Clinical Trial Registration: ChiCTR2300067951, www.chictr.org.cn 01 February, 2023.
摘要：
在这项随机对照试验中，纳入74例妇科腹腔镜手术患者（美国麻醉医师协会I/II级），随机分为两个研究组：（i）C组（对照组），接受舒芬太尼（0.3μg/kg）和生理盐水，其次是舒芬太尼（0.1μg/kg·h）和生理盐水；（ii）F组（OFA），服用艾氯胺酮（0.15mg/kg）和利多卡因（2mg/kg），其次是艾氯胺酮（0.1毫克/千克·h）和利多卡因（1.5毫克/千克·h）。主要结果是术后疼痛评分的48小时时间加权平均值（TWA）。次要结果包括拔管时间，不利影响，术后镇静评分,不同时间点的疼痛评分，镇痛消耗在48小时，和胃肠功能恢复。F组和C组疼痛评分的48小时TWAs分别为1.32(0.78)(95%CI1.06-1.58)和1.09(0.70)(95%CI0.87-1.33),分别。F组和C组之间的估计差异为-0.23（95％CI-0.58-0.12；P=0.195）。在任何次要结局中没有发现差异，并且在两组中均没有观察到严重的不良反应。在择期妇科腹腔镜手术患者中，利多卡因和艾氯胺酮的平衡OFA与舒芬太尼的平衡麻醉效果相似，没有严重的不良反应。临床试验注册：ChiCTR2300067951，www。chictr.org.cn2月1日，2023年。
