Adrenocortical AbnormalityNCT03188029
Cortisol Level After Repeated Doses of Etomidate
A study testing adrenocortical function in people with Adrenocortical Abnormality, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
The aim of this study is to investigate the effect of repeated doses of etomidate on the adrenocortical synthesis of corticosteroids in patients aged 18 to 65, ASA status I to III scheduled to electroconvulsive therapy every 2 days for 3 to 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adrenocortical Abnormality
- What is being tested?
- adrenocortical function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTunisia
- Study dates
- 3 Oct 2017to 31 Dec 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65,
- ASA status I to III
- and scheduled to electroconvulsive therapy under general anesthesia every 2 days for 3 to 4 weeks
Who cannot join
- previously documented adrenocortical insufficiency
- or under corticosteroid medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Repeated Doses of Etomidate on the Adrenocortical Function
The aim of this study is to investigate the effect of repeated doses of etomidate on the adrenocortical synthesis of corticosteroids in patients aged 18 to 65, ASA status I to III scheduled to electroconvulsive therapy every 2 days for 3 to 4 weeks.
Anesthesia protocol is standardized with 0.5 mg/kg propofol, 0.3 mg/kg etomidate and 0.5 mg/kg succinylcholine.
Read more
Blood samples for cortisol dosage are performed immediately before the first session (baseline cortisol), 24 hours after the first session, 24 hours after the third session and 24 hours after the sixth session. All blood samples are performed at 9 and collected in normal tube.
sample were analysed using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal value are between 6.2-19.4 µg/dL . Sample analysis was performed by a biochemist blinded to clinical detail.
Read the detailed description
The aim of this study is to investigate the effect of repeated doses of etomidate on the adrenocortical synthesis of corticosteroids in patients scheduled to electroconvulsive therapy under general anesthesia
Patients aged 18 to 65, ASA status I to III and scheduled to electroconvulsive therapy under general anesthesia every 2 days for 3 to 4 weeks, are included in this prospective observational study. Patients with previously documented adrenocortical insufficiency or under corticosteroid medication are not included Anesthesia protocol is standardized with 0.5 mg/kg propofol, 0.3 mg/kg etomidate and 0.5 mg/kg succinylcholine. Induction of anesthesia is performed after 3 minutes of preoxygenation with 6 l/min fresh gas flow with 100% inspired fraction of oxygen. The patients are maintained in facial mask ventilation until recovery. During the procedure heart rate, non-invasive blood pressure, pulsed oximetry and end tidal carbon dioxyde are monitored.
Blood samples for cortisol dosage are performed immediately before the first session (baseline cortisol = C0), 24 hours after the first session (cortisol after a single dose of etomidate = C1), 24 hours after the third session (cortisol after 3 doses of etomidate = C3) and 24 hours after the sixth session (cortisol after six doses of etomidate = C6). All blood samples are performed at 9 and collected in normal tube.
Blood samples were centrifuged (4000 tours during 10 minutes) and congealed at -20°. All congealed samples were analyzed at the end of the recruitment, using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal value are between6.2-19.4 µg/dL . Sample analysis was performed by a biochemist blinded to clinical detail.
For every end point time, heart rate and blood pressure are noted. Blood samples for glycaemia, sodium, potassium and bicarbonates are performed at the same rate.
End point criteria and statistical analysis:
Delta-1-cortisol is defined as the difference between C0 and C1 Delta-3-cortisol is defined as the difference between C0 and C3 Delta-6-cortisol is defined as the difference between C0 and C6 We planned to enroll 30 patients during the twelve months.
Wilcoxon test for depended data will be used to compare:
- Conditions
- Adrenocortical Abnormality
- Being tested
- adrenocortical function
- Keywords
- ethomidate adrenocortical insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adrenocortical functionDiagnostic test
Blood samples for cortisol dosage are performed and 24 hours after the sixth session. All blood samples are performed at 9 and collected in normal tube.
Blood samples for glycaemia, sodium, potassium and bicarbonates are performed at the same rate.
| Study group | Role | What they receive |
|---|---|---|
| adrenocortical function | Experimental | repeated general anesthesia with 0.3 mg/kg etomidate, 0.5 mg/kg propofol and 0.5 mg/kg succinylcholine, every 2 days for 3 to 4 weeks for electroconvulsive therapy. Receives: Diagnostic Test: adrenocortical function |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of blood cortisol level
blood cortisal (µg.L) using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal value are between 6.2-19.4 µg/dL
Measured: up to one week
Secondary outcomes (4)
blood glucose
glycaemia (g.L)
Measured: up to one week
blood sodium
sodium (mmol.L)
Measured: up to one week
blood potassium
potassium (mmol.L)
Measured: up to one week
blood bicarbonates
bicarbonates (mmol.L)
Measured: up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start3 Oct 2017
- Primary completion30 Nov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenocortical AbnormalityStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The aim of this study is to investigate the effect of repeated doses of etomidate on the adrenocortical synthesis of corticosteroids in patients scheduled to electroconvulsive therapy every 2 days for 3 to 4 weeks. Anesthesia protocol is standardized with 0.5 mg/kg propofol, 0.3 mg/kg etomidate and 0.5 mg/kg succinylcholine. Blood samples for cortisol dosage are performed immediately before the first session, 24 hours after the first session, 24 hours after the third session and 24 hours after the sixth session. All blood samples are performed at 9 AM. Samples were analyzed at the end of the recruitment, using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal value are between 6.2-19.4 µg/dL.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaabachi olfa, University Tunis El Manar
- Investigators
- RADDAOUI KHAIRREDINE, MD, Study director, KASSAB ORTHOPEDIC INSTITUTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188029
- Sponsor's protocol ID
- 102/2017
- Status last verified
- Jan 2020
- First submitted
- 4 Jun 2017
- Last updated
- 14 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Doses of Etomidate on the Adrenocortical Function
- ClinicalTrials.gov ID
- NCT03188029
- Acronym / sponsor ID
- 102/2017
- Conditions
- Adrenocortical Abnormality
- Keywords
- ethomidate adrenocortical insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 Jun 2017 (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.
The aim of this study is to investigate the effect of repeated doses of etomidate on the adrenocortical synthesis of corticosteroids in patients aged 18 to 65, ASA status I to III scheduled to electroconvulsive therapy every 2 days for 3 to 4 weeks.
Anesthesia protocol is standardized with 0.5 mg/kg propofol, 0.3 mg/kg etomidate and 0.5 mg/kg succinylcholine.
Blood samples for cortisol dosage are performed immediately before the first session (baseline cortisol), 24 hours after the first session, 24 hours after the third session and 24 hours after the sixth session. All blood samples are performed at 9 and collected in normal tube.
sample were analysed using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal value are between 6.2-19.4 µg/dL . Sample analysis was performed by a biochemist blinded to clinical detail.
Detailed description
The aim of this study is to investigate the effect of repeated doses of etomidate on the adrenocortical synthesis of corticosteroids in patients scheduled to electroconvulsive therapy under general anesthesia
Patients aged 18 to 65, ASA status I to III and scheduled to electroconvulsive therapy under general anesthesia every 2 days for 3 to 4 weeks, are included in this prospective observational study. Patients with previously documented adrenocortical insufficiency or under corticosteroid medication are not included Anesthesia protocol is standardized with 0.5 mg/kg propofol, 0.3 mg/kg etomidate and 0.5 mg/kg succinylcholine. Induction of anesthesia is performed after 3 minutes of preoxygenation with 6 l/min fresh gas flow with 100% inspired fraction of oxygen. The patients are maintained in facial mask ventilation until recovery. During the procedure heart rate, non-invasive blood pressure, pulsed oximetry and end tidal carbon dioxyde are monitored.
Blood samples for cortisol dosage are performed immediately before the first session (baseline cortisol = C0), 24 hours after the first session (cortisol after a single dose of etomidate = C1), 24 hours after the third session (cortisol after 3 doses of etomidate = C3) and 24 hours after the sixth session (cortisol after six doses of etomidate = C6). All blood samples are performed at 9 and collected in normal tube.
Blood samples were centrifuged (4000 tours during 10 minutes) and congealed at -20°. All congealed samples were analyzed at the end of the recruitment, using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal value are between6.2-19.4 µg/dL . Sample analysis was performed by a biochemist blinded to clinical detail.
For every end point time, heart rate and blood pressure are noted. Blood samples for glycaemia, sodium, potassium and bicarbonates are performed at the same rate.
End point criteria and statistical analysis:
Delta-1-cortisol is defined as the difference between C0 and C1 Delta-3-cortisol is defined as the difference between C0 and C3 Delta-6-cortisol is defined as the difference between C0 and C6 We planned to enroll 30 patients during the twelve months.
Wilcoxon test for depended data will be used to compare:
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The aim of this study is to investigate the effect of repeated doses of etomidate on the adrenocortical synthesis of corticosteroids in patients scheduled to electroconvulsive therapy every 2 days for 3 to 4 weeks. Anesthesia protocol is standardized with 0.5 mg/kg propofol, 0.3 mg/kg etomidate and 0.5 mg/kg succinylcholine. Blood samples for cortisol dosage are performed immediately before the first session, 24 hours after the first session, 24 hours after the third session and 24 hours after the sixth session. All blood samples are performed at 9 AM. Samples were analyzed at the end of the recruitment, using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal value are between 6.2-19.4 µg/dL.
| Arm | Type | Receives |
|---|---|---|
| adrenocortical function | Experimental | Diagnostic Test: adrenocortical functionrepeated general anesthesia with 0.3 mg/kg etomidate, 0.5 mg/kg propofol and 0.5 mg/kg succinylcholine, every 2 days for 3 to 4 weeks for electroconvulsive therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 65,
- ASA status I to III
- and scheduled to electroconvulsive therapy under general anesthesia every 2 days for 3 to 4 weeks
Key exclusion criteria (2 listed)
- previously documented adrenocortical insufficiency
- or under corticosteroid medication
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 |
|---|---|---|
| adrenocortical functionBlood samples for cortisol dosage are performed and 24 hours after the sixth session. All blood samples are performed at 9 and collected in normal tube. Blood samples for glycaemia, sodium, potassium and bicarbonates are performed at the same rate. | Diagnostic test | adrenocortical function |
Primary outcome
evolution of blood cortisol level
Time frame: up to one week
blood cortisal (µg.L) using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal value are between 6.2-19.4 µg/dL
4 secondary outcomes
blood glucose
Time frame: up to one week
blood sodium
Time frame: up to one week
blood potassium
Time frame: up to one week
blood bicarbonates
Time frame: up to one week
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 14 Jan 2020.
- Individual participant dataSharing planned: Undecided
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.
RADDAOUI KHAIRREDINE, MD study director
KASSAB ORTHOPEDIC INSTITUTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adrenocortical function in people with Adrenocortical Abnormality, run by University Tunis El Manar at 1 site in Tunisia.
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 3 inclusion and 2 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 14 Jan 2020. 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 Tunisia. 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?
evolution of blood cortisol level (time frame: up to one week). 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 14 Jan 2020.