Desflurane-induced Myocardial Protection

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Keio University
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Nobuyuki Katori, Keio University
ClinicalTrials.gov Identifier:
NCT02019797
First received: December 18, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted

December 18, 2013
December 18, 2013
January 2014
December 2015   (final data collection date for primary outcome measure)
Troponin I [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Length of ICU stay, Length of hospital stay [ Time Frame: up to 2 months after the surgery ] [ Designated as safety issue: No ]
  • Acute myocardial infarction [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Desflurane-induced Myocardial Protection
Desflurane-induced Myocardial Protection in Aortic Valve Surgery: A Pilot Study

This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery.

Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass are included in the study. Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a TIVA during the surgery. All patients receive a continuous infusion of remifentanil. Biomarker of myocardial damage troponin I is examined at 4 points; T1: after the induction of anesthesia, T2: arrival at ICU, T3: 12 hours after the ICU arrival, T4: 24 hours after the ICU arrival, T5: third post operative day (3POD).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Aortic Valve Stenosis
Drug: Desflurane
Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and before cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a propofol during the surgery.
Other Name: SUPRANE
  • Experimental: Desflurane
    Desflurane inhalation at 1-2 MAC during surgery.
    Intervention: Drug: Desflurane
  • Active Comparator: Propofol
    5-8 mg/kg/hr infusion during surgery.
    Intervention: Drug: Desflurane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
December 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass.

Exclusion Criteria:

  • Patients younger than 20 years old.
  • Recent myocardial infarction (within 1 year).
  • Renal dysfunction (GFR less than 50ml/min).
  • Known allergy to study drugs including propofol.
Both
20 Years to 90 Years
No
Contact: Nobuyuki Katori, M.D. 81-3-3353-1211 ext 61608 nbyk@a5.keio.jp
Contact: Hiroshi Morisaki, M.D. 81-3-3353-1211 ext 61608 morisaki@z8.keio.jp
Japan
 
NCT02019797
Desflurane
Yes
Nobuyuki Katori, Keio University
Nobuyuki Katori
Baxter Healthcare Corporation
Study Chair: Makoto Suematsu, M.D., Ph.D Keio University, School of Medicine
Keio University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP