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

June 30, 2011 updated by: Baskent University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Özgür Kömürcü
  • Phone Number: +90 312 215 99 41
  • Email: zgrkom@gmail.com

Study Contact Backup

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06490
        • Recruiting
        • Baskent University, Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ketamine
Drug: Ketamine
During standard anesthesia induction with fentanyl and midazolam, ketamine 2 mg/kg IV will be administered
Active Comparator: Etomidate
Drug: Etomidate
During standard anesthesia induction with fentanyl and midazolam, etomidate 3 mg/kg IV will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A more than 15% change in mean arterial pressure and heart rate after anesthesia induction
Time Frame: For 60 minutes after anesthesia induction
For 60 minutes after anesthesia induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adrenal gland steroid synthesis suppression
Time Frame: 24 hours and 5 days after study drug administration
A less than 9 microgram/dl increase in serum cortisol after stimulation with adrenocorticotropic hormone
24 hours and 5 days after study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

  • Principal Investigator: Özgür Kömürcü, Baskent University, Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

June 30, 2011

First Posted (Estimate)

July 1, 2011

Study Record Updates

Last Update Posted (Estimate)

July 1, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-10-114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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