Adrenocortical Abnormality Clinical Trial
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.
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.
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:
;