Objective To assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery. Design Phase III, randomised, double blind, placebo controlled trial. Setting 34 centres in France, December 2017 to March 2019. Participants 1222 adults (>50 years) requiring major non-cardiac surgery with an expected duration of more than 90 minutes. The anticipated time frame for recruitment was 24 months. Interventions Participants were randomised to receive either dexamethasone (0.2 mg/kg immediately after the surgical procedure, and on day 1) or placebo. Randomisation was stratified on the two prespecified criteria of cancer and thoracic procedure. Main outcomes measures The primary outcome was a composite of postoperative complications or all cause mortality within 14 days after surgery, assessed in the modified intention-to-treat population (at least one treatment administered). Results Of the 1222 participants who underwent randomisation, 1184 (96.9%) were included in the modified intention-to-treat population. 14 days after surgery, 101 of 595 participants (17.0%) in the dexamethasone group and 117 of 589 (19.9%) in the placebo group had complications or died (adjusted odds ratio 0.81, 95% confidence interval 0.60 to 1.08; P=0.15). In the stratum of participants who underwent non-thoracic surgery (n=1038), the primary outcome occurred in 69 of 520 participants (13.3%) in the dexamethasone group and 93 of 518 (18%) in the placebo group (adjusted odds ratio 0.70, 0.50 to 0.99). Adverse events were reported in 288 of 613 participants (47.0%) in the dexamethasone group and 296 of 609 (48.6%) in the placebo group (P=0.46). Conclusions Dexamethasone was not found to significantly reduce the incidence of complications and death in patients 14 days after major non-cardiac surgery. The 95% confidence interval for the main result was, however, wide and suggests the possibility of important clinical effectiveness. Trial registration ClinicalTrials.gov [NCT03218553][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03218553&atom=%2Fbmj%2F373%2Fbmj.n1162.atom

中文翻译：

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地塞米松对非心脏大手术后并发症或全因死亡率的影响：多中心、双盲、随机对照试验

目的评估地塞米松对非心脏大手术后并发症或全因死亡率的影响。设计 III 期、随机、双盲、安慰剂对照试验。2017 年 12 月至 2019 年 3 月在法国设立 34 个中心。 参与者 1222 名成人（>50 岁）需要进行预计持续时间超过 90 分钟的重大非心脏手术。预计招聘时间为 24 个月。干预 参与者随机接受地塞米松（手术后立即和第 1 天 0.2 mg/kg）或安慰剂。根据癌症和胸部手术这两个预先指定的标准对随机化进行分层。主要结果测量主要结果是术后并发症或术后 14 天内全因死亡率的复合，在改良的意向治疗人群中进行评估（至少给予一种治疗）。结果 在接受随机分组的 1222 名参与者中，1184 名 (96.9%) 被纳入改良意向治疗人群。手术后 14 天，地塞米松组 595 名参与者中有 101 名 (17.0%) 和安慰剂组 589 名参与者中有 117 名 (19.9%) 出现并发症或死亡（调整后的优势比为 0.81，95% 置信区间为 0.60 至 1.08；P=0.15） ）。在接受非胸外科手术的参与者层 (n=1038) 中，地塞米松组 520 名参与者中的 69 名 (13.3%) 和安慰剂组 518 名参与者中的 93 名 (18%) 出现主要结果（调整后的优势比） 0.70、0.50 到 0.99）。地塞米松组 613 名参与者中有 288 名（47.0%）报告了不良事件，安慰剂组 609 名参与者中有 296 名（48.6%）报告了不良事件（P=0.46）。结论 未发现地塞米松可显着降低非心脏大手术后 14 天患者并发症和死亡的发生率。然而，主要结果的 95% 置信区间很宽，表明可能具有重要的临床有效性。试验注册 ClinicalTrials.gov [NCT03218553][1]。[1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03218553&atom=%2Fbmj%2F373%2Fbmj.n1162.atom