A Comparison of Etomidate and Ketamine for Anesthesia Induction in Coronary Artery Bypass Graft Surgery

Coronary Artery Bypass Surgery Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01386229
• Other study ID #: KA-10-114
• Status: Recruiting
• Phase: Phase 4
• First received: June 21, 2011
• Last updated: June 30, 2011
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2011
• Source: Baskent University
• Contact: Özgür Kömürcü
• Phone: +90 312 215 99 41
• Email: zgrkom[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine whether ketamine is an acceptable alternative to etomidate for anesthesia induction in coronary artery bypass graft surgery in terms of hemodynamic stability and also to compare these agents regarding their effect on adrenal gland steroid synthesis in these patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for elective coronary artery bypass graft surgery with cardiopulmonary bypass

• Patient's written informed consent for study participation

• Ejection fraction = 35%

Exclusion Criteria:

• Allergy to study drugs

• Redo surgery

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery

Intervention

Drug:
• Ketamine
During standard anesthesia induction with fentanyl and midazolam, ketamine 2 mg/kg IV will be administered
• Etomidate
During standard anesthesia induction with fentanyl and midazolam, etomidate 3 mg/kg IV will be administered

Locations

Country	Name	City	State
Turkey	Baskent University, Faculty of Medicine	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A more than 15% change in mean arterial pressure and heart rate after anesthesia induction		For 60 minutes after anesthesia induction	Yes
Secondary	Adrenal gland steroid synthesis suppression	A less than 9 microgram/dl increase in serum cortisol after stimulation with adrenocorticotropic hormone	24 hours and 5 days after study drug administration	Yes