Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation

February 11, 2014 updated by: University Health Network, Toronto

Comparison of Propofol Based Anesthesia and Postoperative Sedation (PA) Versus Volatile Anesthetics Based Anesthesia and Postoperative Sedation (VA) in Cardiac Surgical Patients

All patients undergoing cardiac surgery require intraoperative anesthesia and short-term postoperative sedation with anesthetic agents after the procedure when patient is in the intensive care unit (ICU). The clinical data obtained so far are concentrating on intraoperative use volatile agents (preconditioning) resulting in better postoperative cardiac function and less release of biochemical markers of myocardial damage. There are no studies investigating whether postoperative use of volatile agents (post conditioning) in cardiac surgical population is improving outcomes. The aim of the present study is to compare total intravenous anesthesia and postoperative sedation versus total volatile anesthesia and postoperative sedation in cardiac surgical population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients scheduled for coronary artery bypass graft surgery with good ventricular function (grade 1-2 ventricle)
  • Signed informed consent

Exclusion criteria:

  • Patients undergoing valvular surgery
  • Severe kidney or liver disease (creatinine > 2.5mg.dL-1 and bilirubin > 2 mg.dL-1)
  • Patients with known hypersensitivity to any of the trial drugs (propofol, volatile anesthetics), e.g. propofol allergy or malignant hyperthermia (induced by volatile anesthetics)
  • Patient with poorly controlled diabetes or on oral anti-diabetic medication (inhibit preconditioning caused by volatile anesthetics)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PA-Intravenous Sedation
Propofol based total intravenous anesthesia and postoperative sedation
Other: Propofol
Propofol for sedation in the CVICU
Other Names:
  • Diprivan
ACTIVE_COMPARATOR: Volatile sedation
Total inhalational anesthesia and postoperative sedation with the AnaConda device
Drug: Isoflurane/sevoflurane
Volatile for sedation in the CVICU while intubated
Other Names:
  • 2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane
  • 2,2,2-trifluoro-1-[trifluoromethyl]ethyl fluoromethyl ether

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The composite primary end point of the trial will be the development of enzymatic signs of myocardial injury or MI, postoperative low output syndrome, or both. Enzymatic MI will be determined after obtaining serial measurements of troponin.
Time Frame: Measurements of troponin levels will be after induction of anesthesia (baseline) and at 0, 2, 4, 8, and 24 h after arrival into the ICU.
Measurements of troponin levels will be after induction of anesthesia (baseline) and at 0, 2, 4, 8, and 24 h after arrival into the ICU.

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of sedation
Time Frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Incidence of delirium
Time Frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Time to readiness for extubation, time to extubation
Time Frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Length of stay within ICU, readiness for discharge from the unit
Time Frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (ESTIMATE)

June 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 06-0159 B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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