Ulku Ozgul, Associate Professor, Inonu University, Department of Anesthesiology and Reanimation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Motor (EMG) seizure duration
研究概览
简要总结
The purpose of the study was to investigate the effects of etomidate or sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles.
详细描述
Twenty-five patients will be a total of 150 ECT treatments in this prospective, double-blinded, crossover study. Each patient will receive either 0.2 mg/kg etomidate (Group 1) or 8% sevoflurane (Group 2) in 100% oxygen at 6 L/min fresh gas flow until loss of consciousness for their initial electroconvulsive therapy session. In subsequent sessions, patients will receive the alternative sevoflurane concentration and then alternated between doses until the sixth session. Muscle paralysis will achieve with 1 mg/kg succinylcholine. Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times will recorde.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Study include 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who schedule for ECT sessions under general anesthesia
排除标准
- •Pregnancy
- •Cerebrovascular disease
- •Unstable cardiovascular disease
- •Chronic obstructive pulmonary disease; and
- •Renal or hepatic failure
研究组 & 干预措施
Etomidate
0.2 mg/kg etomidate during anesthesia induction
干预措施: Etomidate (Drug)
Etomidate
0.2 mg/kg etomidate during anesthesia induction
干预措施: Sevoflurane (Drug)
8% sevoflurane
Sevoflurane 8% concentration during anesthesia induction
干预措施: Etomidate (Drug)
8% sevoflurane
Sevoflurane 8% concentration during anesthesia induction
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Motor (EMG) seizure duration
时间窗: intraoperative
Motor seizure duration in electroconvulsive therapy
electroencephalography (EEG) seizure duration
时间窗: intraoperative
seizure duration in electroconvulsive therapy
次要结局
- mean arterial pressure (MAP)((approximately 5 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes)
- heart rate (HR),((approximately 5 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes)
- recovery times((approximately 5 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes)
研究者
Ülkü Özgül
Associate Professor
Inonu University