右美托咪定联合羟考酮用于开放性胰十二指肠切除术围手术期辅助镇痛的随机对照研究

Dexmedetomidine combined with oxycodone for perioperative adjuvant analgesia in patients undergoing open pancreaticoduodenectomy:a randomized controlled clinical trial

目的右美托咪定应用于开放性胰十二指肠切除术患者围手术期辅助镇痛的临床观察。方法选取2020年1月—2021年12月接受开放性胰十二指肠切除手术的患者。本实验采用随机、单盲平行对照的非劣性实验设计,计算出试验所需最低样本量为103例/组,按照10%的脱落失访率,估算每组例数为116例,确定总样本量为232例,将232例患者随机分为羟考酮组(OXY组,n=116)和右美托咪定联合羟考酮组(DEX组,n=116)。主要观察指标为两组患者术后48 h运动状态下(即患者非静止状态)的视觉模拟疼痛评分(visual analogue scale,VAS),次要观察指标为围手术期镇痛药物的使用剂量、术后Ramsay镇静评分,以及两组患者术中肿瘤切除、术后拔管时的血流动力学差异,并记录两组患者术后不良反应和满意度。结果与OXY组相比,DEX组患者术后48 h运动状态下VAS评分低于OXY组(P<0.01),围手术期其他镇痛药物使用量更少(P<0.01)。DEX组患者术后镇静效果优于OXY组(P<0.01);DEX组患者术中及拔管时心率、平均动脉压水平较低(P<0.01);DEX组患者恶心呕吐发生率低于OXY组,满意度高于OXY组,差异具有统计学意义(P<0.05)。结论右美托咪定在开放性胰十二指肠切除术围手术期具有良好的辅助镇痛镇静的作用,可减少围手术期阿片类药物的使用剂量,副反应少,安全性更高。

Objective To investigate dexmedetomidine for perioperative adjuvant analgesia in patients undergoing open pancreaticoduodenectomy.Methods A randomized,double-blind,parallel control and non-inferior clinical trial was conducted between January 2020 and December 2021,232 patients undergoing open pancreaticoduodenectomy were enrolled.There were 116 patients receiving oxycodone for perioperative adjuvant analgesia(OXY group),while another 116 patients receiving oxycodone plus dexmedetomidine(DEX group).The visual analogue scale(VAS)of the patients was observed at 48 h after operation in motion as primary index;while perioperative dose of analgesic drugs,postoperative Ramsay sedation score,hemodynamic parameters during tumor resection and postoperative extubation and postoperative adverse reactions and satisfaction of patients were observed as secondary indexes.Results Compared with OXY group,DEX group had lower VAS scores at rest and at 48 h after operation in motion than OXY group(P<0.01).Less analgesic drugs were used in DEX group during the perioperative period(P<0.01).The DEX group had better sedation than the OXY group postoperatively(P<0.01);DEX group had lower heart rate and mean arterial pressure during operation and during extubation(P<0.01);the incidence of nausea and vomiting during surgery was lower in the DEX group than that in the OXY group,and the satisfaction rate was higher than OXY group(P<0.05).Conclusion Dexmedetomidine has a good adjuvant analgesic and sedative effect in the perioperative period of open pancreatoduodenectomy,which can reduce the dose of opioids used during the perioperative period,with less side effects and higher safety.