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Cortisol Level After Repeated Doses of Etomidate

Primary Purpose

Adrenocortical Abnormality

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
adrenocortical function
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adrenocortical Abnormality focused on measuring ethomidate adrenocortical insufficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Razi Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adrenocortical function

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

blood glucose
glycaemia (g.L)
blood sodium
sodium (mmol.L)
blood potassium
potassium (mmol.L)
blood bicarbonates
bicarbonates (mmol.L)

Full Information

First Posted
June 4, 2017
Last Updated
January 12, 2020
Sponsor
University Tunis El Manar
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1. Study Identification

Unique Protocol Identification Number
NCT03188029
Brief Title
Cortisol Level After Repeated Doses of Etomidate
Official Title
Effect of Repeated Doses of Etomidate on the Adrenocortical Function
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar

4. Oversight

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

5. Study Description

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.
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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenocortical Abnormality
Keywords
ethomidate adrenocortical insufficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adrenocortical function
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
adrenocortical function
Intervention Description
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 Measure Information:
Title
evolution of blood cortisol level
Description
blood cortisal (µg.L) using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal value are between 6.2-19.4 µg/dL
Time Frame
up to one week
Secondary Outcome Measure Information:
Title
blood glucose
Description
glycaemia (g.L)
Time Frame
up to one week
Title
blood sodium
Description
sodium (mmol.L)
Time Frame
up to one week
Title
blood potassium
Description
potassium (mmol.L)
Time Frame
up to one week
Title
blood bicarbonates
Description
bicarbonates (mmol.L)
Time Frame
up to one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RADDAOUI KHAIRREDINE, MD
Organizational Affiliation
KASSAB ORTHOPEDIC INSTITUTE
Official's Role
Study Director
Facility Information:
Facility Name
Razi Hospital
City
Tunis
State/Province
La Manouba
ZIP/Postal Code
2010
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Cortisol Level After Repeated Doses of Etomidate

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