Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation

Not Applicable

Completed

• Conditions: Cardiac Surgery
• Interventions: Other: Propofol; Drug: Isoflurane/sevoflurane

• Registration Number: NCT01151254
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-28
• Primary Completion: 2012-01
• Study Completion: 2013-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PA-Intravenous Sedation	Propofol	Propofol based total intravenous anesthesia and postoperative sedation
Volatile sedation	Isoflurane/sevoflurane	Total inhalational anesthesia and postoperative sedation with the AnaConda device

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
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)

Trial Locations

Locations (1)

Toronto General Hopsital; 🇨🇦 Toronto, Ontario, Canada