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

May 2, 2025 updated by: Elliott Bennett-Guerrero, Stony Brook University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1826

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Roswell Park Cancer Center
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794-8480
        • Stony Brook University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol infusion
Maintenance of general anesthesia with propofol infusion
Drug: Propofol
Maintenance of general anesthesia with propofol infusion
Experimental: Volatile agent
Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)
Drug: Volatile Agent
Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 2 year minimum
Time to event
2 year minimum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival
Time Frame: Minimum 2 years
Time to event
Minimum 2 years
All-cause mortality as a binary outcome
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2017

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

January 22, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimated)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 967670-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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