Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862753
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2022-01-11
Brief Title:
Duration and Depth of Anesthesia Induced by a Bolus of Etomidate
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
Evaluating Duration and Depth of Anesthesia by Bispectral Index Induced by an Induction Dose of Etomidate
Status:
COMPLETED
Status Verified Date:
2022-01
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:
Induction of general anesthesia requires to be safe and to ensure a proper level of anesthesia A proper anesthesia is sufficient to guarantee loss of consciousness and amnesia and without being too depth leading to a electroencephalogram EEG with burst suppression The depth of anesthesia is monitored by the bispectral index analyse of the EEG this allows to detect any under- or over-dose of anesthesia The monitoring works with an unknown algorithm patent which evaluate the state of consciousness in the patient
Etomidate and propofol are commonly use to ensure general anesthesia Actually really few litterature has objective informations about the monitoring of Etomidate The few existant are the old ones and has just a clinical evaluation of the depth of anesthesia loss of consciousness loss of breathing loss of palpebral reflex Except the fact that these clinical evaluations come from the brain stem and in fact are not reliable to assess the cortical activity which is reduced by etomidate
Therefore some anesthetists are fearful that etomidate is not sufficient to ensure a proper anesthesia to intubate the patient
This interventionnal study has two purpose Firstly a survey will be conduct about the habits and beliefs when use of etomidate
Secondly a prospective study will be conduct to monitore with the bispectral index the depth and duration of anesthesia with etomidate
Etomidate and propofol are commonly use to ensure general anesthesia Actually really few litterature has objective informations about the monitoring of Etomidate The few existant are the old ones and has just a clinical evaluation of the depth of anesthesia loss of consciousness loss of breathing loss of palpebral reflex Except the fact that these clinical evaluations come from the brain stem and in fact are not reliable to assess the cortical activity which is reduced by etomidate
Therefore some anesthetists are fearful that etomidate is not sufficient to ensure a proper anesthesia to intubate the patient
This interventionnal study has two purpose Firstly a survey will be conduct about the habits and beliefs when use of etomidate
Secondly a prospective study will be conduct to monitore with the bispectral index the depth and duration of anesthesia with etomidate
Detailed Description:
Protocol with randomization in one of the 2 arms 02 vs 03 mg kg of etomidate blind to the investigators
The right dosage will be prepared at the same time by a colleague anesthetist who will not participate in the study according to the randomization envelope that we will give to him earlier To remain blind to this dosage it will be diluted with physiological serum up to 30 ml
These following procedures will be carried out in order
- Preparation by a colleague of the adequate dose of etomidate reduced to 20 cc with physiological serum
No premedication with benzodiazepines xanax
Standard monitoring ECG NIBP SpO2
Monitoring the depth of anesthesia by bispectral analysis of the electroencephalography BIS trace
Placement of a peripheral venous line 18 or 20 G at the bend of the elbow vein of good size to avoid potential discomfort during the injection of etomidate
Preoxygenation with a face mask
Start remifentanil 20 μg ml in AIVOC mode with a site-effect concentration Cet of 2 μg ml and wait for an equilibration
Injection of the induction dose of etomidate over 30 seconds
After loss of consciousness curarisation with 06 mgkg rocuronium
Observation period of the depth of anesthesia Ventilation support by light ventilation with a face mask
Special attention will be paid to avoid any interference with the BIS recording do not move the patient to set it up do not turn on the heating blanket
When the BIS rises above 60 the study stops The anesthesia is then deepened by administration of propofol and is left to the discretion of the anesthesiologist in charge of the room
The right dosage will be prepared at the same time by a colleague anesthetist who will not participate in the study according to the randomization envelope that we will give to him earlier To remain blind to this dosage it will be diluted with physiological serum up to 30 ml
These following procedures will be carried out in order
- Preparation by a colleague of the adequate dose of etomidate reduced to 20 cc with physiological serum
No premedication with benzodiazepines xanax
Standard monitoring ECG NIBP SpO2
Monitoring the depth of anesthesia by bispectral analysis of the electroencephalography BIS trace
Placement of a peripheral venous line 18 or 20 G at the bend of the elbow vein of good size to avoid potential discomfort during the injection of etomidate
Preoxygenation with a face mask
Start remifentanil 20 μg ml in AIVOC mode with a site-effect concentration Cet of 2 μg ml and wait for an equilibration
Injection of the induction dose of etomidate over 30 seconds
After loss of consciousness curarisation with 06 mgkg rocuronium
Observation period of the depth of anesthesia Ventilation support by light ventilation with a face mask
Special attention will be paid to avoid any interference with the BIS recording do not move the patient to set it up do not turn on the heating blanket
When the BIS rises above 60 the study stops The anesthesia is then deepened by administration of propofol and is left to the discretion of the anesthesiologist in charge of the room
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None