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NCT03034096 Clinical Trial

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

Anesthesia, General Clinical Trial

— GA-CARES  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03034096
Other study ID # 967670-3
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date January 31, 2017
Est. completion date December 2024

Study information
Verified date March 2024
Source Stony Brook University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1804
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol
Maintenance of general anesthesia with propofol infusion
• Volatile Agent
Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)

Locations
Country Name City State
United States 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 Stony Brook University Hospital Stony Brook New York

Sponsors (1)
Lead Sponsor Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality Time to event 2 year minimum
Secondary Recurrence free survival Time to event Minimum 2 years
Secondary All-cause mortality as a binary outcome 2 years
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