Desflurane-induced Myocardial Protection

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02019797
• Other study ID #: Desflurane
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 18, 2013
• Last updated: December 18, 2013
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2013
• Source: Keio University
• Contact: Nobuyuki Katori, M.D.
• Phone: 81-3-3353-1211
• Email: nbyk[@]a5.keio.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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.

Locations

Country	Name	City	State
Japan	Keio University Hospital	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Nobuyuki Katori	Baxter Healthcare Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin I		up to 3 days	No
Secondary	Length of ICU stay, Length of hospital stay		up to 2 months after the surgery	No
Secondary	Acute myocardial infarction		up to 7 days	No