Effect of Repeated Doses of Etomidate on the Adrenocortical Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- evolution of blood cortisol level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •previously documented adrenocortical insufficiency
- •or under corticosteroid medication
研究组 & 干预措施
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.
干预措施: adrenocortical function (Diagnostic Test)
结局指标
主要结局
evolution of blood cortisol level
时间窗: 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
次要结局
- blood bicarbonates(up to one week)
- blood glucose(up to one week)
- blood sodium(up to one week)
- blood potassium(up to one week)
研究者
Kaabachi olfa
professor
University Tunis El Manar