Clinical trial NCT01151254: Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation
Official title: Comparison of Propofol Based Anesthesia and Postoperative Sedation (PA) Versus Volatile Anesthetics Based Anesthesia and Postoperative Sedation (VA) in Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Cardiac Surgery
Sedation
Intensive care
Volatile anesthesia
Intravenous anesthesia
Pre and post conditioning after cardiac surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: Quality of sedation
timeFrame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
measure: Incidence of delirium
timeFrame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
measure: Time to readiness for extubation, time to extubation
timeFrame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
measure: Length of stay within ICU, readiness for discharge from the unit
timeFrame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hopsital
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: Marcin Wasowicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wasowicz M, Jerath A, Luksun W, Sharma V, Mitsakakis N, Meineri M, Katznelson R, Yau T, Rao V, Beattie WS. Comparison of propofol-based versus volatile-based anaesthesia and postoperative sedation in cardiac surgical patients: a prospective, randomized, study. Anaesthesiol Intensive Ther. 2018;50(3):200-209. doi: 10.5603/AIT.a2018.0012. Epub 2018 Jun 18.
citation: Pickworth T, Jerath A, DeVine R, Kherani N, Wasowicz M. The scavenging of volatile anesthetic agents in the cardiovascular intensive care unit environment: a technical report. Can J Anaesth. 2013 Jan;60(1):38-43. doi: 10.1007/s12630-012-9814-5. Epub 2012 Nov 7.