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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03034096
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
Elliott Bennett-Guerrero, Stony Brook University

Tracking Information
First Submitted Date  ICMJE January 22, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date October 17, 2022
Actual Study Start Date  ICMJE January 31, 2017
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)		 All-cause mortality [ Time Frame: 2 year minimum ]
Time to event
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Recurrence free survival [ Time Frame: Minimum 2 years ]
    Time to event
  • All-cause mortality as a binary outcome [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial
Official Title  ICMJE General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anesthesia, General
  • Surgical Oncology
Intervention  ICMJE
  • Drug: Propofol
    Maintenance of general anesthesia with propofol infusion
  • Drug: Volatile Agent
    Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)
Study Arms  ICMJE
  • Experimental: Propofol infusion
    Maintenance of general anesthesia with propofol infusion
    Intervention: Drug: Propofol
  • Experimental: Volatile agent
    Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)
    Intervention: Drug: Volatile Agent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 13, 2022)		 1804
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)		 2000
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034096
Other Study ID Numbers  ICMJE 967670-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Elliott Bennett-Guerrero, Stony Brook University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stony Brook University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stony Brook University
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP