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Completed

NCT Number: NCT03034096

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

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.

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Key information

Conditions

Anesthesia, General Surgical Oncology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Roswell Park Cancer Center, Buffalo, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Maintenance of general anesthesia with propofol infusion

Volatile agent

Drug

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

Primary outcomes

  1. All-cause mortality

    Time frame: 2 year minimum

    Time to event

Secondary outcomes

  1. Recurrence free survival

    Time frame: Minimum 2 years

    Time to event

  2. All-cause mortality as a binary outcome

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

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

Acronym: GA-CARES

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2017
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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