Desflurane-induced Myocardial Protection
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 24, 2013
December 1, 2013
1.9 years
December 18, 2013
December 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Troponin I
up to 3 days
Secondary Outcomes (2)
Length of ICU stay, Length of hospital stay
up to 2 months after the surgery
Acute myocardial infarction
up to 7 days
Study Arms (2)
Desflurane
EXPERIMENTALDesflurane inhalation at 1-2 MAC during surgery.
Propofol
ACTIVE COMPARATOR5-8 mg/kg/hr infusion during surgery.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nobuyuki Katorilead
- Baxter Healthcare Corporationcollaborator
Study Sites (1)
Keio University Hospital
Tokyo, 160-8582, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Makoto Suematsu, M.D., Ph.D
Keio University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 18, 2013
First Posted
December 24, 2013
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
December 24, 2013
Record last verified: 2013-12