The Effects of Sevoflurane or Ketamine on QTc Interval During Electroconvulsive Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluation Of QT interval
研究概览
简要总结
The aim of this study was to evaluate the effect of sevoflurane or ketamine on the QTc and Tp-e interval during in patients with major depression.
详细描述
Patients enrolled in the study are randomly allocated by computer-generated random numbers to receive either sevoflurane or ketamine for their initial ECT session. They subsequently receive an alternative study drug in their next session, continuing to alternate between drugs at each session until the sixth session. In group S, sevoflurane are initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus is delivered, In group K, ketamine are given to 1mg/kg ıv bolus.
Electrical stimulus is delivered via bilateral frontotemporal electrodes.The mean arterial pressure (MAP), HR, and ECG are recorded before anesthetic induction (T1), after anesthetic induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6, respectively).The QT interval and Tp-e interval are measured by one author, who was unaware of group allocation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unpremedicated
- •American Society of Anesthesiologists (ASA) I-II the patients
- •Major depressions patients scheduled for ECT sessions
排除标准
- •with permanent pacemakers,
- •diabetes mellitus,
- •atrial fibrillation,
- •electrolyte imbalance,
- •patients taking antiarrhythmics and β-blockers.
研究组 & 干预措施
Group S
In group S, sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered, at which time it was turned off.
干预措施: Sevoflurane (Drug)
Group K
In group K, ketamine was given to 1mg/kg ıv bolus.
干预措施: Ketamine (Drug)
结局指标
主要结局
Evaluation Of QT interval
时间窗: 10 minutes
ECG were recorded before anesthetic induction (T1), after anesthetic induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6, respectively)during ECT anesthesia with sevoflurane and ketamine.The QT interval was measured by one author, who was unaware of group allocation.
次要结局
- Evaluation of Tp-e interval(10 minutes)
- Seizure durations(120 seconds)