General Anesthetics in CAncer REsection Surgery (General Anesthetics in Cancer Resection (GA-CARES)) randomized multicenter trial of propofol vs volatile inhalational anesthesia: protocol description
Study context
- Population
- Adults with known or suspected cancer undergoing one of eight oncologic surgeries with a high risk of cancer recurrence, five sites in New York Stateenrolment completed
- Participants
- 1,804 adults
- Comparison
- Propofol vs volatile agent for maintenance of general anesthesia (GA)
- Primary endpoint
- Overall survival (assumed 5% absolute difference, 85% vs 90%)
- Follow-up
- 2 years (minimum 2-year )
Methodological detailspragmatic, phase 3, multicentre, 1:1 randomisation stratified by center and surgery type, no planned interim analyses, Target enrolment 1800; power 97.4% (two-sided log-rank test, type I error 0.05), Data from National Death Index, New York (NY) Cancer Registry and electronic harvesting from electronic medical records (EMR)
- Pragmatic
- Phase 3
- Multicentre
- 1:1 randomisation stratified by center and surgery type
- No planned interim analyses
- Target enrolment 1800; power 97.4% (two-sided log-rank test, type I error 0.05)
- Data from National Death Index, NY Cancer Registry and electronic harvesting from EMR
Primary result
As reported in the abstract
- Enrolment completed; study in follow-up phase (no results reported)
Original publication
General Anesthetics in CAncer REsection Surgery (GA-CARES) randomized multicenter trial of propofol vs volatile inhalational anesthesia: protocol description. Perioper Med (Lond). Published 11 January 2023. doi:10.
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