Brief Title
Desflurane-induced Myocardial Protection
Official Title
Desflurane-induced Myocardial Protection in Aortic Valve Surgery: A Pilot Study
Brief Summary
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.
Detailed Description
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).
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Troponin I
Secondary Outcome
Length of ICU stay, Length of hospital stay
Condition
Aortic Valve Stenosis
Intervention
Desflurane
Study Arms / Comparison Groups
Desflurane
Description: Desflurane inhalation at 1-2 MAC during surgery.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
50
Start Date
January 2014
Completion Date
December 2016
Primary Completion Date
December 2015
Eligibility Criteria
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.
Gender
All
Ages
20 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Makoto Suematsu, M.D., Ph.D, 81-3-3353-1211, [email protected]
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT02019797
Organization ID
Desflurane
Responsible Party
Sponsor-Investigator
Study Sponsor
Nobuyuki Katori
Collaborators
Baxter Healthcare Corporation
Study Sponsor
Makoto Suematsu, M.D., Ph.D, Study Chair, Keio University
Verification Date
December 2013