Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451776
Status:
COMPLETED
Last Update Posted:
2008-10-31
First Post:
2007-03-22
Brief Title:
Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC A Prospective Monocentric Randomised Double Blind Study
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-007017-21 | None | None | None |