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Clinical Trials/NCT01151254
NCT01151254
Completed
N/A

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

University Health Network, Toronto1 site in 1 country146 target enrollmentSeptember 2009

Overview

Phase
N/A
Intervention
Propofol
Conditions
Cardiac Surgery
Sponsor
University Health Network, Toronto
Enrollment
146
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
12 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

PA-Intravenous Sedation

Propofol based total intravenous anesthesia and postoperative sedation

Intervention: Propofol

Volatile sedation

Total inhalational anesthesia and postoperative sedation with the AnaConda device

Intervention: Isoflurane/sevoflurane

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Quality of sedation(Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge))
  • Incidence of delirium(Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge))
  • Time to readiness for extubation, time to extubation(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(Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge))

Study Sites (1)

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