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

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ClinicalTrials.gov Identifier: NCT01386229
Recruitment Status : Unknown
Verified June 2011 by Baskent University.
Recruitment status was:  Recruiting
First Posted : July 1, 2011
Last Update Posted : July 1, 2011
Sponsor:
Information provided by:
Baskent University

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Surgery Drug: Ketamine Drug: Etomidate Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. A more than 15% change in mean arterial pressure and heart rate after anesthesia induction [ Time Frame: For 60 minutes after anesthesia induction ]

Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386229


Contacts
Contact: Özgür Kömürcü +90 312 215 99 41 zgrkom@gmail.com
Contact: Arash Pirat +90 312 212 68 68 ext 1800 araspirat@gmail.com

Locations
Turkey
Baskent University, Faculty of Medicine Recruiting
Ankara, Çankaya, Turkey, 06490
Sponsors and Collaborators
Baskent University
Investigators
Principal Investigator: Özgür Kömürcü Baskent University, Faculty of Medicine

Responsible Party: Özgür Kömürcü, Baskent University, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01386229     History of Changes
Other Study ID Numbers: KA-10-114
First Posted: July 1, 2011    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: June 2011

Keywords provided by Baskent University:
hemodynamic stability
etomidate
ketamine
coronary artery bypass surgery after induction of anesthesia, hemodynamic stability

Additional relevant MeSH terms:
Anesthetics
Ketamine
Etomidate
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives