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Desflurane-induced Myocardial Protection

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ClinicalTrials.gov Identifier: NCT02019797
Recruitment Status : Unknown
Verified December 2013 by Nobuyuki Katori, Keio University.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2013
Last Update Posted : December 24, 2013
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Nobuyuki Katori, Keio University

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Drug: Desflurane Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desflurane-induced Myocardial Protection in Aortic Valve Surgery: A Pilot Study
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Desflurane
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Troponin I [ Time Frame: up to 3 days ]

Secondary Outcome Measures :
  1. Length of ICU stay, Length of hospital stay [ Time Frame: up to 2 months after the surgery ]
  2. Acute myocardial infarction [ Time Frame: up to 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nobuyuki Katori, Assistant Professor, Keio University
ClinicalTrials.gov Identifier: NCT02019797     History of Changes
Other Study ID Numbers: Desflurane
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Keywords provided by Nobuyuki Katori, Keio University:
aortic valve replacement

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Propofol
Desflurane
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation