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

Phase 4

Completed

• Conditions: Anesthesia, General; Surgical Oncology
• Interventions: Drug: Propofol; Drug: Volatile Agent

• Registration Number: NCT03034096
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-22
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Study Start: 2017-01-31
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1826

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol infusion	Propofol	Maintenance of general anesthesia with propofol infusion
Volatile agent	Volatile Agent	Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)

Primary Outcome Measures

Name	Time	Method
All-cause mortality	2 year minimum	Time to event

Secondary Outcome Measures

Name	Time	Method
Recurrence free survival	Minimum 2 years	Time to event
All-cause mortality as a binary outcome	2 years

Trial Locations

Locations (5)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, 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