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Cortisol Level After Repeated Doses of Etomidate

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ClinicalTrials.gov Identifier: NCT03188029
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Kaabachi olfa, University Tunis El Manar

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Adrenocortical Abnormality Diagnostic Test: adrenocortical function Not Applicable

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:


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Effect of Repeated Doses of Etomidate on the Adrenocortical Function
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Etomidate

Arm Intervention/treatment
Experimental: adrenocortical function
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.
Diagnostic Test: adrenocortical function

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. blood glucose [ Time Frame: up to one week ]
    glycaemia (g.L)

  2. blood sodium [ Time Frame: up to one week ]
    sodium (mmol.L)

  3. blood potassium [ Time Frame: up to one week ]
    potassium (mmol.L)

  4. blood bicarbonates [ Time Frame: up to one week ]
    bicarbonates (mmol.L)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • previously documented adrenocortical insufficiency
  • or under corticosteroid medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188029


Contacts
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Contact: BOUSSELMI RADHOUAN, MD +21622622495 rdh.bousselmi@gmail.com
Contact: ZOGLAMI KARIMA, MD +21621595524 zoghlamikarima@gmail.com

Locations
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Tunisia
Razi Hospital Recruiting
Tunis, La Manouba, Tunisia, 2010
Contact: BOUSSELMI RADHOUAN, MD    +21622622495    rdh.bousselmi@gmail.com   
Contact: ZOGLAMI KARIMA, MD    +21621595524    zoghlamikarima@gmail.com   
Sponsors and Collaborators
University Tunis El Manar
Investigators
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Study Director: RADDAOUI KHAIRREDINE, MD KASSAB ORTHOPEDIC INSTITUTE

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Responsible Party: Kaabachi olfa, professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03188029     History of Changes
Other Study ID Numbers: 102/2017
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaabachi olfa, University Tunis El Manar:
ethomidate adrenocortical insufficiency

Additional relevant MeSH terms:
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Etomidate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics