术前地塞米松对疑似阑尾炎腹腔镜手术后恶心和呕吐的随机临床试验。
Randomized clinical trial of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopy for suspected appendicitis.
机构信息
Departments of Surgery, Nordsjaellands Hospital, Copenhagen University Hospital, Hillerød, Denmark.
Køge Sygehus, Zealand University Hospital, Køge, Denmark.
出版信息
Br J Surg. 2017 Mar;104(4):384-392. doi: 10.1002/bjs.10418. Epub 2017 Jan 10.
BACKGROUND
Few studies have investigated the effects of preoperative dexamethasone in acute surgical patients. This study examined the effects of 8 mg dexamethasone administered intravenously 30 min before surgery for suspected acute appendicitis.
METHODS
A multicentre, parallel-group, double-blind, placebo-controlled study was conducted at two university hospitals in Denmark. Adults undergoing laparoscopic surgery for suspected appendicitis were eligible for inclusion. Participants, healthcare staff and investigators were blinded until all data analysis had been done. The primary outcome was the incidence of postoperative nausea and vomiting (PONV) during the first postoperative day. Secondary outcomes were pain, fatigue, sleep, opioid consumption, use of antiemetics, quality of recovery and duration of convalescence. Analysis was done according to the intention-to-treat principle.
RESULTS
A total of 120 patients were enrolled; 57 patients in the dexamethasone group and 59 in the placebo group were eligible for primary analysis. In the dexamethasone group, 47 (95 per cent c.i. 35 to 60) per cent of patients experienced PONV compared with 63 (50 to 74) per cent) in the placebo group. The absolute risk reduction in PONV was 15 (-3 to 33) per cent in favour of the dexamethasone group (P = 0·098). Patients in the dexamethasone group had less pain at rest (difference in score on visual analogue scale (VAS) 9 (95 per cent c.i. 1 to 17) mm; P = 0·024), were less fatigued (difference in VAS score 7 (0 to 14) mm; P = 0·038), used fewer opioids (absolute risk reduction 17 (2 to 33) per cent; P = 0·033) and had better quality of recovery (difference in QoR-15 score 13 (4 to 22); P = 0·006) during the first postoperative day. There was no difference in postoperative complications (P = 0·595).
CONCLUSION
Preoperative dexamethasone did not reduce PONV by the target level of 50 per cent. Registration number: NCT02415335 ( http://www.clinicaltrials.gov).
背景
很少有研究调查术前使用地塞米松对急性外科手术患者的影响。本研究旨在探讨在怀疑患有急性阑尾炎的患者中，术前 30 分钟静脉注射 8mg 地塞米松的效果。
方法
这是一项在丹麦两所大学医院进行的多中心、平行分组、双盲、安慰剂对照研究。接受腹腔镜手术治疗疑似阑尾炎的成年人符合纳入标准。参与者、医护人员和研究人员在完成所有数据分析之前均处于盲态。主要结局是术后第一天发生术后恶心和呕吐（PONV）的发生率。次要结局是疼痛、疲劳、睡眠、阿片类药物消耗、止吐药使用、恢复质量和康复时间。分析按照意向治疗原则进行。
结果
共纳入 120 例患者；其中，57 例患者在地塞米松组，59 例患者在安慰剂组符合主要分析标准。在地塞米松组，47 例（95%可信区间 35 至 60）患者发生 PONV，而安慰剂组有 63 例（50 至 74）患者发生 PONV。地塞米松组 PONV 的绝对风险降低 15 个百分点（-3 至 33，P=0.098）。地塞米松组患者在休息时疼痛程度较轻（视觉模拟评分差值 9（95%可信区间 1 至 17）mm；P=0.024），疲劳程度较轻（视觉模拟评分差值 7（0 至 14）mm；P=0.038），阿片类药物使用量较少（绝对风险降低 17 个百分点（2 至 33，P=0.033）），且在术后第一天恢复质量更好（QoR-15 评分差值 13（4 至 22）；P=0.006）。两组术后并发症发生率无差异（P=0.595）。
结论
术前使用地塞米松并未将 PONV 的发生率降低到 50%的目标水平。注册号：NCT02415335（http://www.clinicaltrials.gov）。
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