General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial

Stony Brook University1,826 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,826

Conditions

Anesthesia, General Surgical Oncology

Interventions

PropofolDRUG

Maintenance of general anesthesia with propofol infusion

Volatile AgentDRUG

Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Roswell Park Cancer Center

Buffalo, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

All-cause mortality

Time to event

Time frame: 2 year minimum

Secondary Outcomes

Recurrence free survival

Time to event

Time frame: Minimum 2 years

All-cause mortality as a binary outcome

Time frame: 2 years

Data from ClinicalTrials.gov

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