Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC
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Purpose
Because of its hemodynamic safety, etomidate is widely used for anaesthesia induction of cardiac surgery. It can also cause adrenal insufficiency during the following 48 hours ( 11 betahydroxylase inhibition ). So it could increase hemodynamic dysfunction caused by the SIRS following cardiopulmonary bypass.
A previous observational study found more adrenal insufficiency and need for vasopressive support therapy in the etomidate group versus another propofol induced group.
The aim of our work is to compare hemodynamic dysfunction following induction with etomidate for cardiac surgery with ECC. The control group would be induced by Propofol. 94 patients would be included.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Surgery |
Drug: etomidate Drug: propofol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC. A Prospective, Monocentric, Randomised Double Blind Study |
- Time to discharge to vasoactive supportive therapy in the first 48 post operative hours . [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Hemodynamic supportive drugs ( I .e : dodutamine and noradrenaline ) doses at different time . [ Time Frame: several times ] [ Designated as safety issue: No ]
- Systematic inflammatory response intensity [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Hemodynamic supportive drugs consumption in patients with SIRS sub group [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Myocardial infarction incidence in the first 48 postoperative hours . [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
- In hospital mortality [ Time Frame: day of hospital coming out ] [ Designated as safety issue: Yes ]
| Enrollment: | 100 |
| Study Start Date: | June 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
patients who received etomidate
|
Drug: etomidate
patients who received etomidate
|
|
Active Comparator: 2
patients who received propofol
|
Drug: propofol
patients who received propofol
|
Detailed Description:
Information will be given at the anaesthetic consultation, few weeks before planed cardiac surgery. Eligibility and exclusion criteria will be checked. Patient will receive an informative written consent notice and all questions will be answered. A standard pre-operative blood collection will be sampled.
In order to minimize the potential confusing effect of daily cortisol variation, only surgical procedure performed early morning will be considered. The day before surgery definitive inclusion will be decided as the order of procedure is not known before. Only patients operated in the morning will be included because of cortisol daily variations. At this time, consent and information notice will be signed and checked in the medical record.
On the morning of surgery, during venous catheter insertion an additional blood sample will be collected to asses basal cortisolemia.
Randomisation will be carried out centrally after patient operative theatre admission, by phone call from ICU to randomisation office. Hypnotic drug will be prepared in the ICU department next to the operative room and blindly administered to patient ( same volume per weight ). All other anesthetic procedures will be standardised : opioid drugs, vasopressive support, antifibrinolytics and hemodynamic monitoring.
After surgery patients are admitted to surgical ICU. They will undergo standard post operative exams plus two corticotrophin tests and a dosage of SIRS markers ( IL6 and TNF alpha ). These results will only be known at the end of the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age superior to 18 years
- patient which had to be operated for aorto-coronary pass and/or valvular replacement
Exclusion Criteria:
- patient with aortics shrinking
- women pregnant or nursing
- contra-indication to etomidate or diprivan or synacthene
- patient with insufficiency kidney
- patient with infection
Contacts and Locations| France | |
| University hospital | |
| Saint-Etienne, France, 42055 | |
| Principal Investigator: | Jérome MOREL, MD | Centre Hospitalier Universitaire de Saint Etienne |
More Information
No publications provided
| Responsible Party: | Dr Jérôme MOREL, Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT00451776 History of Changes |
| Other Study ID Numbers: | 0608119, 2006-007017-21 |
| Study First Received: | March 22, 2007 |
| Last Updated: | October 29, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
|
cardiac surgery adrenal insufficiency etomidate propofol |
Additional relevant MeSH terms:
|
Anesthetics Etomidate Propofol Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General |
ClinicalTrials.gov processed this record on June 18, 2013