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Desflurane-induced Myocardial Protection

Primary Purpose

Aortic Valve Stenosis

Status

Unknown status

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Desflurane

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring aortic valve replacement

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Keio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Desflurane

Propofol

Arm Description

Desflurane inhalation at 1-2 MAC during surgery.

5-8 mg/kg/hr infusion during surgery.

Outcomes

Primary Outcome Measures

Troponin I

Secondary Outcome Measures

Length of ICU stay, Length of hospital stay

Acute myocardial infarction

Full Information

NCT ID

NCT02019797

First Posted

December 18, 2013

Last Updated

December 18, 2013

Sponsor

Nobuyuki Katori

Collaborators

Baxter Healthcare Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02019797

Brief Title

Desflurane-induced Myocardial Protection

Official Title

Desflurane-induced Myocardial Protection in Aortic Valve Surgery: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nobuyuki Katori

Collaborators

Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

Keywords

aortic valve replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Desflurane

Arm Type

Experimental

Arm Description

Desflurane inhalation at 1-2 MAC during surgery.

Arm Title

Propofol

Arm Type

Active Comparator

Arm Description

5-8 mg/kg/hr infusion during surgery.

Intervention Type

Drug

Intervention Name(s)

Desflurane

Other Intervention Name(s)

SUPRANE

Intervention Description

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.

Primary Outcome Measure Information:

Title

Troponin I

Time Frame

up to 3 days

Secondary Outcome Measure Information:

Title

Length of ICU stay, Length of hospital stay

Time Frame

up to 2 months after the surgery

Title

Acute myocardial infarction

Time Frame

up to 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nobuyuki Katori, M.D.

Phone

81-3-3353-1211

Ext

61608

nbyk@a5.keio.jp

First Name & Middle Initial & Last Name or Official Title & Degree

Hiroshi Morisaki, M.D.

Phone

81-3-3353-1211

Ext

61608

morisaki@z8.keio.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Makoto Suematsu, M.D., Ph.D

Organizational Affiliation

Keio University

Official's Role

Study Chair

Facility Information:

Facility Name

Keio University Hospital

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nobuyuki Katori, M.D.

Phone

81-3-3353-1211

Ext

61608

nbyk@a5.keio.jp

First Name & Middle Initial & Last Name & Degree

Hiroshi Morisaki, M.D.

Phone

81-3-3353-1211

Ext

61608

morisaki@z8.keio.jp

First Name & Middle Initial & Last Name & Degree

Hiroshi Morisaki, M.D.

First Name & Middle Initial & Last Name & Degree

Nobuyuki Katori, M.D.

12. IPD Sharing Statement

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Desflurane-induced Myocardial Protection

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