Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgery

Treatments: Drug: etomidate; Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT00451776

2006-007017-21

0608119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

1

Experimental group

Description:

patients who received etomidate

Treatment:

Drug: etomidate

2

Active Comparator group

Description:

patients who received propofol

Treatment:

Drug: propofol