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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

Tracking Information
First Submitted Date  ICMJE June 21, 2011
First Posted Date  ICMJE July 1, 2011
Last Update Posted Date July 1, 2011
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
A more than 15% change in mean arterial pressure and heart rate after anesthesia induction [ Time Frame: For 60 minutes after anesthesia induction ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Etomidate and Ketamine for Anesthesia Induction in Coronary Artery Bypass Graft Surgery
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Bypass Surgery
Intervention  ICMJE
  • Drug: Ketamine
    During standard anesthesia induction with fentanyl and midazolam, ketamine 2 mg/kg IV will be administered
  • Drug: Etomidate
    During standard anesthesia induction with fentanyl and midazolam, etomidate 3 mg/kg IV will be administered
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Intervention: Drug: Ketamine
  • Active Comparator: Etomidate
    Intervention: Drug: Etomidate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 30, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01386229
Other Study ID Numbers  ICMJE KA-10-114
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Özgür Kömürcü, Baskent University, Faculty of Medicine
Study Sponsor  ICMJE Baskent University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Özgür Kömürcü Baskent University, Faculty of Medicine
PRS Account Baskent University
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP