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

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ClinicalTrials.gov Identifier: NCT03034096
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Elliott Bennett-Guerrero, 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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Surgical Oncology Drug: Propofol Drug: Volatile Agent Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia
Study Start Date : January 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: Propofol infusion
Maintenance of general anesthesia with propofol infusion
Drug: Propofol
Maintenance of general anesthesia with propofol infusion

Experimental: Volatile agent
Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)
Drug: Volatile Agent
Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 2 year minimum ]
    Time to event


Secondary Outcome Measures :
  1. Recurrence free survival [ Time Frame: Minimum 2 years ]
    Time to event

  2. All-cause mortality as a binary outcome [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034096


Locations
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United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Yashar Ettekal, MD       EttekaY@amc.edu   
Principal Investigator: Yashar Ettekal, MD         
Roswell Park Cancer Center Recruiting
Buffalo, New York, United States, 14203
Contact: Timothy Quinn, MD       timothy.quinn@roswellpark.org   
Principal Investigator: Timothy Quinn, MD         
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Sanjeev Ponnappan, MD       SPonnappan@northwell.edu   
Principal Investigator: Sanjeev Ponnappan, MD         
Sub-Investigator: Linda Shore-Lesserson, MD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Samuel Demaria, MD       samuel.demaria@mountsinai.org   
Sub-Investigator: Parissa Tabrizian, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jacob Nadler, MD PhD       Jacob_Nadler@URMC.Rochester.edu   
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794-8480
Contact: Elliott Bennett-Guerrero, MD       elliott.bennett-guerrero@stonybrookmedicine.edu   
Sub-Investigator: Aaron Sasson, MD         
Sub-Investigator: Jie Yang, PhD         
Sponsors and Collaborators
Stony Brook University

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Responsible Party: Elliott Bennett-Guerrero, Professor and Vice Chairman, Stony Brook University
ClinicalTrials.gov Identifier: NCT03034096     History of Changes
Other Study ID Numbers: 967670-3
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Anesthetics
Propofol
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous