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
  Purpose

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.


Condition Intervention Phase
Aortic Valve Stenosis
Drug: Desflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desflurane-induced Myocardial Protection in Aortic Valve Surgery: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Keio University:

Primary Outcome Measures:
  • Troponin I [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desflurane
Desflurane inhalation at 1-2 MAC during surgery.
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
Active Comparator: Propofol
5-8 mg/kg/hr infusion during surgery.
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

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).

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019797

Contacts
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

Locations
Japan
Keio University Hospital Not yet recruiting
Tokyo, Japan, 160-8582
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   
Principal Investigator: Hiroshi Morisaki, M.D.         
Sub-Investigator: Nobuyuki Katori, M.D.         
Sponsors and Collaborators
Nobuyuki Katori
Baxter Healthcare Corporation
Investigators
Study Chair: Makoto Suematsu, M.D., Ph.D Keio University, School of Medicine
  More Information

No publications provided

Responsible Party: Nobuyuki Katori, Assistant Professor, Keio University
ClinicalTrials.gov Identifier: NCT02019797     History of Changes
Other Study ID Numbers: Desflurane
Study First Received: December 18, 2013
Last Updated: December 18, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Keio University:
aortic valve replacement

Additional relevant MeSH terms:
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction
Desflurane
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014