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
Recruitment status was Recruiting
Sponsor:
Baskent University
Information provided by:
Baskent University
ClinicalTrials.gov Identifier:
NCT01386229
First received: June 21, 2011
Last updated: June 30, 2011
Last verified: June 2011
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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
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 Anesthetics, Dissociative Anesthetics, Intravenous |
Anesthetics, General Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on June 18, 2013