AnesthesiaNCT05862753
Duration and Depth of Anesthesia Induced by a Bolus of Etomidate
A study testing induction by Etomidate bolus in people with Anesthesia, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- induction by Etomidate bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Jan 2022to 20 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I, ASA II, schedule for minor or moderate surgery.
Who cannot join
- Dependance to alcohol, to drugs, morphinique or psychotrop.
- Epilepsia of severe CNS impairement
- Body weight <70% or >130% to ideal body weight.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Duration and Depth of Anesthesia by Bispectral Index Induced by an Induction Dose of Etomidate.
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.
Read more
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.
Read the detailed description
Protocol with randomization in one of the 2 arms (0.2 vs. 0.3 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 0,6 mg/kg (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.
- Conditions
- Anesthesia
- Being tested
- induction by Etomidate bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induction by Etomidate bolusDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Etomidate 0,2 mg/kg | Experimental | 8 patients recruited, to receive an injection of bolus of Etomidate at dosage 0,2 mg/kg, Receives: 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 Receives: Drug: induction by Etomidate bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to loss of consciousness
Time for loss of consciousness after etomidate administration
Measured: During general anesthesia induction
time to loss of palpebral reflex
Time to loss of palpebral reflex after etomidate administration
Measured: During general anesthesia induction
Time for BIS decrease < 60
Time for BIS decrease < 60 after etomidate administration
Measured: During general anesthesia induction
Duration of adequate general anesthesia
Time spent with a bis < 60 after etomidate administration
Measured: During general anesthesia induction
Secondary outcomes (1)
Presence of secondary effect of etomidate, about presence of myoclonia
Myoclonia
Measured: During first 15 minutes of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start11 Jan 2022
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Boudart, MD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862753
- Sponsor's protocol ID
- SRB2021349
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Duration and Depth of Anesthesia by Bispectral Index Induced by an Induction Dose of Etomidate.
- ClinicalTrials.gov ID
- NCT05862753
- Acronym / sponsor ID
- SRB2021349
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Protocol with randomization in one of the 2 arms (0.2 vs. 0.3 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 0,6 mg/kg (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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate 0,2 mg/kg | Experimental | Drug: induction by Etomidate bolus8 patients recruited, to receive an injection of bolus of Etomidate at dosage 0,2 mg/kg, |
| Etomidate 0,3 mg/kg | Experimental | Drug: induction by Etomidate bolus10 patients recruited, to receive an injection of bolus of Etomidate at dosage 0,3 mg/kg |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I, ASA II, schedule for minor or moderate surgery.
Key exclusion criteria (3 listed)
- Dependance to alcohol, to drugs, morphinique or psychotrop.
- Epilepsia of severe CNS impairement
- Body weight <70% or >130% to ideal body weight.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| induction by Etomidate bolusGeneral 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. | Drug | Etomidate 0,2 mg/kg, Etomidate 0,3 mg/kg |
Primary outcome
time to loss of consciousness
Time frame: During general anesthesia induction
Time for loss of consciousness after etomidate administration
time to loss of palpebral reflex
Time frame: During general anesthesia induction
Time to loss of palpebral reflex after etomidate administration
Time for BIS decrease < 60
Time frame: During general anesthesia induction
Time for BIS decrease < 60 after etomidate administration
Duration of adequate general anesthesia
Time frame: During general anesthesia induction
Time spent with a bis < 60 after etomidate administration
1 secondary outcome
Presence of secondary effect of etomidate, about presence of myoclonia
Time frame: During first 15 minutes of general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline Boudart, MD principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing induction by Etomidate bolus in people with Anesthesia, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to loss of consciousness (time frame: During general anesthesia induction). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.