Millions of patients receive general anaesthesia every year with either propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA). It is currently unknown which of these techniques is superior in relation to patient experience, safety and clinical outcomes. The primary aims of this trial are to determine (1) whether patients undergoing (a) major inpatient surgery, (b) minor inpatient surgery or (c) outpatient surgery have a superior quality of recovery after INVA or TIVA and (2) whether TIVA confers no more than a small (0.2%) increased risk of definite intraoperative awareness than INVA.
This protocol was co-created by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 13 000-patient, multicentre, patient-blinded, randomised, comparative effectiveness trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to one of two anaesthetic approaches, TIVA or INVA, using minimisation. The primary effectiveness endpoints are Quality of Recovery-15 (QOR-15) score on postoperative day (POD) 1 in patients undergoing (1) major inpatient surgery, (2) minor inpatient surgery or (3) outpatient surgery, and the primary safety endpoint is the incidence of unintended definite intraoperative awareness with recall in all patients, assessed on POD1 or POD30. Secondary endpoints include QOR-15 score on POD0, POD2 and POD7; incidence of delirium on POD0 and POD1; functional status on POD30 and POD90; health-related quality of life on POD30, POD90, POD180 and POD365; days alive and at home at POD30; patient satisfaction with anaesthesia at POD2; respiratory failure on POD0; kidney injury on POD7; all-cause mortality at POD30 and POD90; intraoperative hypotension; moderate-to-severe intraoperative movement; unplanned hospital admission after outpatient surgery in a free-standing ambulatory surgery centre setting; propofol-related infusion syndrome and malignant hyperthermia.
This study is approved by the ethics board at Washington University, serving as the single Institutional Review Board for all participating sites. Recruitment began in September 2023. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.
Amid growing concerns about primary care accessibility and the need to support longitudinal, community-based models of care, Canadian provinces have implemented major reforms to how family physicians are paid. These models share objectives of making longitudinal, community-based family practice more attractive and, to some degree, addressing long-standing disparities in pay between family medicine and other specialties. These new remuneration models require robust evaluation to guide improvements, future investments and planning.
We will conduct a multimethod study to explore physician perceptions and outcomes of these new models. First, we will complete semi-structured interviews with family physicians in British Columbia, Manitoba and Nova Scotia (provinces where a new blended compensation model has been introduced). Interviews will explore family physicians’ motivations for moving onto the blended compensation model; how the model has impacted their practice, administrative burden, visit length, capacity, changes to care coordination; and other areas of interest. Second, using provincial and national administrative datasets, we will assess the impact of these payment reforms on service volume, attachment/enrolment, continuity of care, and costs.
We have obtained cross-jurisdictional ethics approvals from Research Ethics British Columbia for the qualitative components and Nova Scotia Health for the quantitative components of this research. Harmonised ethics approvals have been obtained from additional institutions across all study regions. We will create summaries of findings of provincial and cross-provincial analyses and share them with relevant policymakers, physician associations and study participants. Our dissemination will also include traditional publications such as peer-reviewed articles, commentaries/editorials, and academic conferences.