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Completed

NCT Number: NCT01151254

Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation

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.

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Key information

Conditions

Cardiac Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hopsital

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Isoflurane/sevoflurane

Drug

Volatile for sedation in the CVICU while intubated

Other names: 2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane, 2,2,2-trifluoro-1-[trifluoromethyl]ethyl fluoromethyl ether

Propofol

Other

Propofol for sedation in the CVICU

Other names: Diprivan

Primary outcomes

  1. 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

  1. Quality of sedation

    Time frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)

  2. Incidence of delirium

    Time frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)

  3. Time to readiness for extubation, time to extubation

    Time frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)

  4. Length of stay within ICU, readiness for discharge from the unit

    Time frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jun 28, 2010
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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