Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Surgery
Intervention: Isoflurane/sevoflurane (Drug); Propofol (Other)
Phase: N/A
Status: Completed
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s): Marcin Wasowicz, MD, Principal Investigator, Affiliation: Toronto General Hospital, University Health Network
Summary
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.
Clinical Details
Official title: Comparison of Propofol Based Anesthesia and Postoperative Sedation (PA) Versus Volatile Anesthetics Based Anesthesia and Postoperative Sedation (VA) in Cardiac Surgical Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: 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.
Secondary outcome: Quality of sedationIncidence of delirium Time to readiness for extubation, time to extubation Length of stay within ICU, readiness for discharge from the unit
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Toronto General Hopsital, Toronto, Ontario M5G 2C4, Canada
Additional Information
Starting date: September 2009
Last updated: February 11, 2014
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