Duration and Depth of Anesthesia Induced by a Bolus of Etomidate

NCT05862753 | Completed

• 1 other identifier: SRB2021349
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (4)

• time to loss of consciousness

  Time for loss of consciousness after etomidate administration

  During general anesthesia induction

• time to loss of palpebral reflex

  Time to loss of palpebral reflex after etomidate administration

  During general anesthesia induction

• Time for BIS decrease < 60

  Time for BIS decrease \< 60 after etomidate administration

  During general anesthesia induction

• Duration of adequate general anesthesia

  Time spent with a bis \< 60 after etomidate administration

  During general anesthesia induction

Secondary Outcomes (1)

• Presence of secondary effect of etomidate, about presence of myoclonia

  During first 15 minutes of general anesthesia

Other Outcomes (1)

• Presence of secondary effect of etomidate, about pain during injection

  During first 15 minutes of general anesthesia

Study Arms (2)

Etomidate 0,2 mg/kg

EXPERIMENTAL

8 patients recruited, to receive an injection of bolus of Etomidate at dosage 0,2 mg/kg,

Drug: induction by Etomidate bolus

Etomidate 0,3 mg/kg

EXPERIMENTAL

10 patients recruited, to receive an injection of bolus of Etomidate at dosage 0,3 mg/kg

Drug: induction by Etomidate bolus

Interventions

induction by Etomidate bolus DRUG

General anesthesia induction by Etomidate bolus with different concentration in either of the two arms. First arm, has the concentration (0,2 mg/kg) commonly used of Etomidate to induce anesthesia. Second arm, has the concentration (0,3 mg/kg) usually proposed in medical literature.

Etomidate 0,2 mg/kg; Etomidate 0,3 mg/kg

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I, ASA II, schedule for minor or moderate surgery.

You may not qualify if:

• Dependance to alcohol, to drugs, morphinique or psychotrop.
• Epilepsia of severe CNS impairement
• Body weight \<70% or \>130% to ideal body weight.

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme UH

Brussels, 1070, Belgium

Location

Study Officials

• Céline Boudart, MD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: May 17, 2023
• Study Start: January 11, 2022
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: May 17, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)