JAMA · 2026
Total Intravenous vs Volatile Inhalational Anesthesia for Major Noncardiac Surgery: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеPragmatic Clinical TrialМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Jhanji Shaman, Booth Katie, Hiller Louise, Braun John, Dunn Janet, Eggleston Lucy, Fenton-May Llewellyn, Frempong Sam, Gilchrist Katie, Jacques Claire, Jefford Monica, Kandiyali Rebecca, Kaur Dalbir, Mason James, Moonesinghe S Ramani, Pearse Rupert, Rao Baikady Ravishankar, Reynolds Toby, Shelley Ben, Sinclair Rhona C F, Teare Thomas, Vindrola-Padros Cecilia, Yeung Joyce, VITAL Trial Team
Аннотация
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.
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.
Предметные рубрики MeSH
AgedFemaleHumansMaleMiddle AgedAnesthesia Recovery PeriodAnesthesia, GeneralAnesthesia, InhalationAnesthesia, IntravenousAnesthetics, InhalationAnesthetics, IntravenousElective Surgical ProceduresPatient SatisfactionPostoperative ComplicationsPropofolFollow-Up StudiesEmergence DeliriumIntraoperative AwarenessAged, 80 and over