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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Baskent University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Baskent University
ClinicalTrials.gov Identifier:
NCT01386229
First received: June 21, 2011
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Coronary Artery Bypass Surgery
Drug: Ketamine
Drug: Etomidate
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Baskent University:

Primary Outcome Measures:
  • A more than 15% change in mean arterial pressure and heart rate after anesthesia induction [ Time Frame: For 60 minutes after anesthesia induction ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adrenal gland steroid synthesis suppression [ Time Frame: 24 hours and 5 days after study drug administration ] [ Designated as safety issue: Yes ]
    A less than 9 microgram/dl increase in serum cortisol after stimulation with adrenocorticotropic hormone


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Özgür Kömürcü, Baskent University, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01386229     History of Changes
Other Study ID Numbers: KA-10-114
Study First Received: June 21, 2011
Last Updated: June 30, 2011
Health Authority: Turkey: Ethics Committee

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on September 11, 2014