Department of Anesthesiology, Peking University First Hospital, Beijing, China.
Department of Anesthesiology, Peking University First Hospital, Beijing, China; Clinical Research Institute, Shenzhen Peking University-The Hong Kong University of Science and Technology Medical Center, Shenzhen, Guangdong, China.
Br J Anaesth. 2023 Aug;131(2):253-265. doi: 10.1016/j.bja.2023.04.024. Epub 2023 Jun 4.
Delirium is a common and disturbing postoperative complication that might be ameliorated by propofol-based anaesthesia. We therefore tested the primary hypothesis that there is less delirium after propofol-based than after sevoflurane-based anaesthesia within 7 days of major cancer surgery.
This multicentre randomised trial was conducted in 14 tertiary care hospitals in China. Patients aged 65-90 yr undergoing major cancer surgery were randomised to either propofol-based anaesthesia or to sevoflurane-based anaesthesia. The primary endpoint was the incidence of delirium within 7 postoperative days.
A total of 1228 subjects were enrolled and randomised, with 1195 subjects included in the modified intention-to-treat analysis (mean age 71 yr; 422 [35%] women); one subject died before delirium assessment. Delirium occurred in 8.4% (50/597) of subjects given propofol-based anaesthesia vs 12.4% (74/597) of subjects given sevoflurane-based anaesthesia (relative risk 0.68 [95% confidence interval {CI}: 0.48-0.95]; P=0.023; adjusted relative risk 0.59 [95% CI: 0.39-0.90]; P=0.014). Delirium reduction mainly occurred on the first day after surgery, with a prevalence of 5.4% (32/597) with propofol anaesthesia vs 10.7% (64/597) with sevoflurane anaesthesia (relative risk 0.50 [95% CI: 0.33-0.75]; P=0.001). Secondary endpoints, including ICU admission, postoperative duration of hospitalisation, major complications within 30 days, cognitive function at 30 days and 3 yr, and safety outcomes, did not differ significantly between groups.
Delirium was a third less common after propofol than sevoflurane anaesthesia in older patients having major cancer surgery. Clinicians might therefore reasonably select propofol-based anaesthesia in patients at high risk of postoperative delirium.
Chinese Clinical Trial Registry (ChiCTR-IPR-15006209) and ClinicalTrials.gov (NCT02662257).
谵妄是一种常见且令人困扰的术后并发症，可能可以通过基于异丙酚的麻醉来缓解。因此，我们检验了主要假设，即在大手术后的 7 天内，基于异丙酚的麻醉比基于七氟醚的麻醉出现谵妄的情况更少。
这项多中心随机试验在中国的 14 家三级护理医院进行。年龄在 65-90 岁之间、接受大手术的癌症患者被随机分配到基于异丙酚的麻醉组或基于七氟醚的麻醉组。主要终点是术后 7 天内发生谵妄的发生率。
共纳入 1228 名受试者并进行随机分组，其中 1195 名受试者纳入改良意向治疗分析（平均年龄 71 岁；422[35%]名女性）；1 名受试者在进行谵妄评估前死亡。基于异丙酚的麻醉组中发生谵妄的患者比例为 8.4%（50/597），而基于七氟醚的麻醉组中发生谵妄的患者比例为 12.4%（74/597）（相对风险 0.68[95%置信区间{CI}：0.48-0.95]；P=0.023；调整后的相对风险 0.59[95%CI：0.39-0.90]；P=0.014）。谵妄的减少主要发生在手术后的第一天，异丙酚麻醉组的发生率为 5.4%（32/597），而七氟醚麻醉组的发生率为 10.7%（64/597）（相对风险 0.50[95%CI：0.33-0.75]；P=0.001）。次要终点，包括 ICU 入院、术后住院时间、30 天内的主要并发症、30 天和 3 年的认知功能以及安全性结果，在两组之间没有显著差异。
在接受大手术的老年患者中，与七氟醚麻醉相比，异丙酚麻醉后谵妄的发生率降低了三分之一。因此，在术后谵妄风险较高的患者中，临床医生可以合理地选择基于异丙酚的麻醉。
中国临床试验注册中心（ChiCTR-IPR-15006209）和 ClinicalTrials.gov（NCT02662257）。
