General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia

Stony Brook University5 sites in 1 country1,826 target enrollmentJanuary 31, 2017

ConditionsAnesthesia, General Surgical Oncology

InterventionsPropofol Volatile Agent

DrugsPropofol Volatile Agent

Overview

Phase: Phase 4
Intervention: Propofol
Conditions: Anesthesia, General
Sponsor: Stony Brook University
Enrollment: 1826
Locations: 5
Primary Endpoint: All-cause mortality
Status: Completed
Last Updated: 12 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.

Registry

clinicaltrials.gov

Start Date

January 31, 2017

End Date

September 30, 2024

Last Updated

12 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stony Brook University

Responsible Party

Principal Investigator

Elliott Bennett-Guerrero

Professor and Vice Chairman

Stony Brook University

Eligibility Criteria

Inclusion Criteria

•Patients with known or suspected cancer and scheduled to undergo any of the following oncologic surgical procedures:
•Lobectomy or pneumonectomy
•Esophagectomy
•Radical (total) cystectomy
•Pancreatectomy
•Partial hepatectomy
•Hyperthermic intraperitoneal chemotherapy (HIPEC)
•Gastrectomy (subtotal or total)
•Cholecystectomy or bile duct resection

Exclusion Criteria

•Age less than 18 years
•American Society of Anesthesiologist Class 5
•Projected life expectancy less than 30 days
•Known or suspected hypersensitivity to either propofol, e.g. egg or soy allergy, or volatile general anesthetic agents
•Known or suspected history of malignant hyperthermia