The Effects of Induction Agents Applied During Electroconvulsive Therapy on Seizure Duration, Seizure Quality, and Recovery Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- EEG Seizure Duration
研究概览
简要总结
The goal of this observational study is to determine if there are any differences in seizure duration, seizure quality, and recovery time associated with the utilize of different anesthetic induction agents in patients undergoing electroconvulsive therapy.
The main question it aims to answer is: Does the choice of anesthetic agent in ECT affect seizure duration, seizure quality, and recovery time? The secondary aim is to measure and compare Patient State Index values on different time of ECT procedure.
Participants were informed in detail about the ECT procedure. It was explained that, prior to the induction of anesthesia, a probe would be placed on the face to measure the PSI. Written informed consent was obtained from all participants.
详细描述
This prospective, randomized controlled study was designed to compare the effects of different anesthetic induction agents used during electroconvulsive therapy (ECT) on seizure characteristics, recovery profile, hemodynamic responses, anesthesia depth, and post-procedural complications. Adult patients scheduled to undergo ECT were randomized into four groups according to the induction agent administered: propofol, thiopental, ketamine, or ketofol.
During each ECT session, seizure duration and postictal suppression index were recorded as indicators of seizure characteristics and seizure quality. Recovery was assessed using the time to reach a Modified Aldrete Score of 9. Hemodynamic parameters, including systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate, and peripheral oxygen saturation, were measured at predefined peri-procedural time points. Patient State Index values obtained using SedLine monitoring were also recorded before induction, before ECT stimulation, 1 minute after stimulation, and during recovery.
Post-procedural complications, including agitation, pain, nausea, and vomiting, were recorded during the recovery period after each ECT session. The study aimed to determine whether different induction agents differ in terms of seizure duration, seizure quality, recovery time, hemodynamic stability, anesthesia depth, and recovery-related adverse events in patients undergoing ECT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors were blinded to group allocation. Randomization was performed using a computer-generated list with sealed envelope allocation. The anesthesiologist administering the induction agent was not involved in outcome assessment.
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
- •Age between 18 and 65 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Clinical indication for electroconvulsive therapy (ECT) determined by a psychiatrist
排除标准
- •ASA physical status IV or higher
- •History of lithium use
- •Pregnancy or breastfeeding
- •History of alcohol or substance abuse
- •History of electroconvulsive therapy (ECT) within the last 2 months
- •Anticipated difficult airway
- •Presence of epilepsy or glaucoma
- •Organ failure (heart failure, renal failure, or hepatic failure)
- •Intracranial mass lesion
- •Thrombophlebitis or deep vein thrombosis
- •Known allergy to anesthetic agents
- •Patients who are unable to complete the ECT session or who refuse to -participate in the study
研究组 & 干预措施
Ketamine Group
Participants in this group received ketamine 0.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
干预措施: Ketamine (0.5 mg/kg) (Drug)
Ketofol Group
Participants in this group received a combination of ketamine 0.5 mg/kg and propofol 0.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
干预措施: Ketofol (Drug)
Propofol Group
Participants in this group received propofol 1.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
干预措施: Propofol group (Drug)
Thiopenthal Group
Participants in this group received thiopental 3 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
干预措施: Thiopental (Drug)
结局指标
主要结局
EEG Seizure Duration
时间窗: During each ECT session, from electrical stimulation until seizure termination, assessed up to 120 seconds after stimulation.
Duration of electroencephalographic (EEG) seizure activity measured in seconds during electroconvulsive therapy using the Thymatron System IV device.
Postictal Suppression Index
时间窗: Immediately after seizure termination during each ECT session, assessed up to 3 minutes after electrical stimulation.
Postictal suppression index (%) automatically calculated by the Thymatron System IV device following seizure termination.
Recovery time
时间窗: From the end of ECT stimulation until achievement of Modified Aldrete Score ≥9, assessed up to 30 minutes after ECT.
Time to Modified Aldrete Score ≥9
次要结局
- Heart Rate(At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation.)
- Patient State Index (PSI)(At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation.)
- Incidence of Post-procedural Complications(During each ECT session and recovery period, assessed up to 30 minutes after electrical stimulation.)
- Mean Arterial Pressure(At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation.)
- Systolic Arterial Pressure(At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation.)
- Diastolic Arterial Pressure(At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation.)
- Peripheral Oxygen Saturation (SpO₂)(At predefined peri-procedural time points during each ECT session: Baseline before anesthetic induction, immediately before ECT stimulation, 1 minute after ECT stimulation, and recovery assessment up to 30 minutes after ECT stimulation.)
研究者
Canan Ezgi Durukan Bas
MD, Resident Physician (Anesthesiology)
Dr. Lutfi Kirdar Kartal Training and Research Hospital