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

Stony Brook University

Status and phase: Completed; Phase 4

Conditions: Surgical Oncology; Anesthesia, General

Treatments: Drug: Propofol; Drug: Volatile Agent

Study type: Interventional

Funder types: Other

Identifiers

NCT03034096

967670-3

Details and patient eligibility

About

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.

Enrollment: 1,826 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,826 participants in 2 patient groups

Propofol infusion

Experimental group

Description:

Maintenance of general anesthesia with propofol infusion

Treatment:

Drug: Propofol

Volatile agent

Experimental group

Description:

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

Treatment:

Drug: Volatile Agent