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Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01151254
Enrollment
146
Registered
2010-06-28
Start date
2009-09-30
Completion date
2013-07-31
Last updated
2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

Cardiac Surgery, Sedation, Intensive care, Volatile anesthesia, Intravenous anesthesia, Pre and post conditioning after cardiac surgery

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.

Interventions

DRUGIsoflurane/sevoflurane

Volatile for sedation in the CVICU while intubated

OTHERPropofol

Propofol for sedation in the CVICU

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Quality of sedationPost ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Incidence of deliriumPost ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Time to readiness for extubation, time to extubationPost 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 unitPost ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026