CHU Nantes, Université de Nantes, Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu, Nantes, France
Service d'Anesthésie, Centre Hospitalier Le Mans, Le Mans, France.
BMJ. 2021 Jun 2;373:n1162. doi: 10.1136/bmj.n1162.
To assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery.
Phase III, randomised, double blind, placebo controlled trial.
34 centres in France, December 2017 to March 2019.
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.
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.
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).
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).
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.
ClinicalTrials.gov NCT03218553.
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。
III 期、随机、双盲、安慰剂对照试验。
2017 年 12 月至 2019 年 3 月，法国 34 个中心。
1222 名年龄大于 50 岁的成年人，需要接受预计持续时间超过 90 分钟的非心脏大手术。预计招募时间为 24 个月。
参与者被随机分配接受地塞米松（手术结束后立即给予 0.2mg/kg，第 1 天给予）或安慰剂。随机分组基于两个预设标准：癌症和胸部手术。
主要结局是手术后 14 天内的术后并发症或全因死亡率的复合结果，在改良意向治疗人群中评估（至少给予一次治疗）。
在接受随机分组的 1222 名参与者中，1184 名（96.9%）纳入改良意向治疗人群。手术后 14 天，地塞米松组 595 名参与者中的 101 名（17.0%）和安慰剂组 589 名参与者中的 117 名（19.9%）发生并发症或死亡（调整后的优势比 0.81，95%置信区间 0.60 至 1.08；P=0.15）。在非胸部手术参与者的亚组（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%）发生主要结局（调整后的优势比 0.70，0.50 至 0.99）。地塞米松组 613 名参与者中的 288 名（47.0%）和安慰剂组 609 名参与者中的 296 名（48.6%）报告了不良事件（P=0.46）。
地塞米松并未显著降低非心脏大手术后 14 天患者的并发症和死亡率发生率。主要结果的 95%置信区间较宽，表明可能存在重要的临床效果。
ClinicalTrials.gov NCT03218553。
