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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 sedation

Incidence 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

Page last updated: August 23, 2015

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