作者
Shaman Jhanji,Katie Booth,Louise Hiller,John Braun,Janet Dunn,Lucy Eggleston,Llewellyn Fenton-May,Sam Frempong,Katie Gilchrist,Claire Jacques,Monica Jefford,Rebecca Kandiyali,Dalbir Kaur,James Mason,S. Ramani Moonesinghe,Rupert Pearse,Ravishankar Rao Baikady,Toby Reynolds,Ben Shelley,Rhona C. F. Sinclair
摘要
Importance: Older adults undergoing major noncardiac surgery experience substantial postoperative morbidity and health care use. The comparative effectiveness of total intravenous anesthesia (TIVA) vs volatile-based inhalational anesthesia on recovery and safety remains uncertain. Objectives: To determine whether TIVA improves days alive and at home at 30 days compared with inhalational anesthesia and to evaluate differences in patient-centered outcomes and recovery. Design, Setting, and Participants: Pragmatic, multicenter, open-label randomized clinical trial conducted in 49 UK National Health Service hospitals from January 2022 to April 2024 (final follow-up, October 2024) among patients aged 50 years or older scheduled for elective major noncardiac surgery. Interventions: Participants were randomized 1:1 to receive maintenance of general anesthesia with either TIVA (propofol infusion) (n = 1254) or volatile-based inhalational agents (n = 1254). All other perioperative care was at clinician discretion. Main Outcomes and Measures: The primary outcome was days alive and at home at 30 days. Secondary outcomes included days alive and at home at 90 days; mortality at 30 days, 90 days, and 6 months; Quality of Recovery-15 score at day 3; patient satisfaction (Bauer Patient Satisfaction Questionnaire) at day 1; delirium (4 As Test [4AT]) at day 3; unintentional awareness under anesthesia; and major postoperative complications within 30 days. Results: Among the 2508 randomized participants, the mean age was 67 (SD, 8.9) years, and 55% were male. Characteristics were balanced across randomized groups. Days alive and at home at 30 days were similar between groups (mean, 22.5 [SD, 6.8] days vs 22.4 [SD, 6.6] days for TIVA vs inhalational anesthesia, respectively; incidence rate ratio, 1.00; 95% CI, 0.99-1.02; adjusted P = .68). There were no differences in days alive and at home at 90 days; mortality at 30 days, 90 days, or 6 months; or Quality of Recovery-15 score at day 3. Lower rates of thirst, hoarseness, and nausea and vomiting were reported in the TIVA group. Levels of delirium were similar between groups, with the majority (87.6%) having no delirium at day 3. Major complications occurred in 12.4% of patients overall, with no significant between-group differences. Two cases of certain or probable unintentional awareness under anesthesia were reported, both in the TIVA group. Conclusions and Relevance: Among older adults undergoing major noncardiac surgery, TIVA did not improve days alive and at home at 30 days compared with inhalational anesthesia. Trial Registration: ISRCTN.org Identifier: ISRCTN62903453.