Sevoflurane Alone and Propofol With or Without Remifentanil in Electroconvulsive Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Seizure duration
研究概览
简要总结
To compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane in ECT.
详细描述
The purpose of this study is to compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane) with respect to seizure duration, postictal suppression index, early and midictal amplitude, hemodynamic variables and recovery profiles in ECT.
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
- Single (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
- •Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,
- •Patients scheduled for six ECT sessions for a variety of psychiatric conditions (major depression, schizophrenia)
排除标准
- •Involuntary patient status
- •Patients with known or self-declared needle or mask phobia
- •Pregnancy
- •Cerebrovascular disease,
- •History of myocardial infarction in the previous 6 months,
- •Atrial fibrillation or flutter,heart block,
- •A known or family history of reactions to the study drugs.
研究组 & 干预措施
propofol (Group P)
The patients in Group P received 1 mg/kg propofol IV (over 15 sec) during anesthesia induction
干预措施: Propofol (Drug)
remifentanil and propofol (Group R)
Patients in Group R received remifentanil 1 µg/kg IV (over 60 sec) and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction
干预措施: Remifentanil and propofol (Drug)
sevoflurane (Group S)
In Group S, sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered, at which time it was stopped.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Seizure duration
时间窗: The patients were observed about seizure up to ten minutes after electrical stimulation
After anesthesia induction patients were administered electrical stimulation and seizure duration were measured.
次要结局
- postictal suppression index(completing seizure in one hour)
- Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands)(after seizure in one hour in operation room.)
- Hemodynamic variables(Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.)
研究者
Zekine Begec
Principal Investigator
Inonu University