Coronary Artery Bypass SurgeryPhase 4NCT01386229
A Comparison of Etomidate and Ketamine for Anesthesia Induction in Coronary Artery Bypass Graft Surgery
A Phase 4 study testing Ketamine and Etomidate in people with Coronary Artery Bypass Surgery, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Bypass Surgery
- What is being tested?
- Ketamine and Etomidate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2011to Mar 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective coronary artery bypass graft surgery with cardiopulmonary bypass
- Patient's written informed consent for study participation
- Ejection fraction ≥ 35%
Who cannot join
- Allergy to study drugs
- Redo surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University, Faculty of Medicine
Ankara, Çankaya, 06490
About this study
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.
- Conditions
- Coronary Artery Bypass Surgery
- Being tested
- Ketamine, Etomidate
- Keywords
- hemodynamic stability, etomidate, ketamine, coronary artery bypass surgery after induction of anesthesia, hemodynamic stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
During standard anesthesia induction with fentanyl and midazolam, ketamine 2 mg/kg IV will be administered
EtomidateDrug
During standard anesthesia induction with fentanyl and midazolam, etomidate 3 mg/kg IV will be administered
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | Not described Receives: Drug: Ketamine |
| Etomidate | Active comparator | Not described Receives: Drug: Etomidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
A more than 15% change in mean arterial pressure and heart rate after anesthesia induction
Measured: For 60 minutes after anesthesia induction
Secondary outcomes (1)
Adrenal gland steroid synthesis suppression
A less than 9 microgram/dl increase in serum cortisol after stimulation with adrenocorticotropic hormone
Measured: 24 hours and 5 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Investigators
- Özgür Kömürcü, Principal investigator, Baskent University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386229
- Sponsor's protocol ID
- KA-10-114
- Status last verified
- Jun 2011
- First submitted
- 21 Jun 2011
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Etomidate and Ketamine for Anesthesia Induction in Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT01386229
- Acronym / sponsor ID
- KA-10-114
- Conditions
- Coronary Artery Bypass Surgery
- Keywords
- hemodynamic stability, etomidate, ketamine, coronary artery bypass surgery after induction of anesthesia, hemodynamic stability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: Ketamine |
| Etomidate | Active comparator | Drug: Etomidate |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective coronary artery bypass graft surgery with cardiopulmonary bypass
- Patient's written informed consent for study participation
- Ejection fraction ≥ 35%
Key exclusion criteria (2 listed)
- Allergy to study drugs
- Redo surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineDuring standard anesthesia induction with fentanyl and midazolam, ketamine 2 mg/kg IV will be administered | Drug | Ketamine |
| EtomidateDuring standard anesthesia induction with fentanyl and midazolam, etomidate 3 mg/kg IV will be administered | Drug | Etomidate |
Primary outcome
A more than 15% change in mean arterial pressure and heart rate after anesthesia induction
Time frame: For 60 minutes after anesthesia induction
1 secondary outcome
Adrenal gland steroid synthesis suppression
Time frame: 24 hours and 5 days after study drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özgür Kömürcü principal investigator
Baskent University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Etomidate in people with Coronary Artery Bypass Surgery, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özgür Kömürcü (+90 312 215 99 41, zgrkom@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A more than 15% change in mean arterial pressure and heart rate after anesthesia induction (time frame: For 60 minutes after anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2011.