Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation

NCT01151254 | Completed

• 1 other identifier: UHN REB 06-0159 B
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Keywords

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

Outcome Measures

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.

  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 (4)

• 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)

Study Arms (2)

PA-Intravenous Sedation

ACTIVE COMPARATOR

Propofol based total intravenous anesthesia and postoperative sedation

Other: Propofol

Volatile sedation

ACTIVE COMPARATOR

Total inhalational anesthesia and postoperative sedation with the AnaConda device

Drug: Isoflurane/sevoflurane

Interventions

Isoflurane/sevoflurane DRUG

Volatile for sedation in the CVICU while intubated

Also known as: 2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane, 2,2,2-trifluoro-1-[trifluoromethyl]ethyl fluoromethyl ether

Volatile sedation

Propofol OTHER

Propofol for sedation in the CVICU

Also known as: Diprivan

PA-Intravenous Sedation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for coronary artery bypass graft surgery with good ventricular function (grade 1-2 ventricle)
• Signed informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hopsital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• 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.

  PMID: 29913033 DERIVED

• 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.

  PMID: 23132045 DERIVED

MeSH Terms

Interventions

Isoflurane; Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Marcin Wasowicz, MD

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: June 28, 2010
• Study Start: September 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2013
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

CA (1)