A Phase 4 interventional study of etomidate and propofol in Cardiac Surgery, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-31.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 4, Interventional, and Treatment
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.
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.
Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients who received etomidate
Drug: etomidate
patients who received propofol
Drug: propofol
patients who received etomidate
patients who received propofol
Time to discharge to vasoactive supportive therapy in the first 48 post operative hours .
Time frame: 48 hours
Hemodynamic supportive drugs ( I .e : dodutamine and noradrenaline ) doses at different time .
Time frame: several times
Systematic inflammatory response intensity
Time frame: 6 hours
Hemodynamic supportive drugs consumption in patients with SIRS sub group
Time frame: 24 hours
Myocardial infarction incidence in the first 48 postoperative hours .
Time frame: 48 hours
In hospital mortality
Time frame: day of hospital coming out
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne