Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151254
• Other study ID #: UHN REB 06-0159 B
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: February 11, 2014
• Start date: September 2009
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• Isoflurane/sevoflurane
Volatile for sedation in the CVICU while intubated

Other:
• Propofol
Propofol for sedation in the CVICU

Locations

Country	Name	City	State
Canada	Toronto General Hopsital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Quality of sedation		Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)	No
Secondary	Incidence of delirium		Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)	No
Secondary	Time to readiness for extubation, time to extubation		Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)	No
Secondary	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)	No