Induction Agents in ECT: Effects on Seizure Duration, Quality, and Recovery
12 мая 2026 г. обновлено: Canan Ezgi Durukan Bas, Dr. Lutfi Kirdar Kartal Training and Research Hospital
The Effects of Induction Agents Applied During Electroconvulsive Therapy on Seizure Duration, Seizure Quality, and Recovery Time
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.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
100
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
Istanbul
-
Istanbul, Istanbul, Турция (Туркие)
- Kartal Dr. Lütfi Kırdar City Hospital
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Propofol Group
Participants in this group received propofol 1.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
|
Propofol administered intravenously at a dose of 1.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Другие имена:
|
|
Экспериментальный: Thiopenthal Group
Participants in this group received thiopental 3 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
|
Thiopental administered intravenously at a dose of 3 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Другие имена:
|
|
Экспериментальный: Ketamine Group
Participants in this group received ketamine 0.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
|
Ketamine administered intravenously at a dose of 0.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Другие имена:
|
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Экспериментальный: 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).
|
Ketofol administered intravenously as a combination of ketamine 0.5 mg/kg and propofol 0.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
EEG Seizure Duration
Временное ограничение: 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.
|
During each ECT session, from electrical stimulation until seizure termination, assessed up to 120 seconds after stimulation.
|
|
Postictal Suppression Index
Временное ограничение: 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.
|
Immediately after seizure termination during each ECT session, assessed up to 3 minutes after electrical stimulation.
|
|
Recovery time
Временное ограничение: 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
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From the end of ECT stimulation until achievement of Modified Aldrete Score ≥9, assessed up to 30 minutes after ECT.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Heart Rate
Временное ограничение: 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.
|
Heart rate was measured in beats per minute using standard peri-procedural monitoring at predefined time points.
|
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)
Временное ограничение: 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) values obtained using the SedLine EEG monitoring system (Masimo Corp., USA), ranging from 0 to 100, reflecting depth of anesthesia.
|
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
Временное ограничение: During each ECT session and recovery period, assessed up to 30 minutes after electrical stimulation.
|
The incidence of post-procedural complications, including hypertension, tachycardia, bradycardia, hypoxemia, agitation, pain, nausea, vomiting, amnesia, was recorded after each ECT session.
|
During each ECT session and recovery period, assessed up to 30 minutes after electrical stimulation.
|
|
Mean Arterial Pressure
Временное ограничение: 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.
|
Mean arterial pressure was measured in millimeters of mercury (mmHg) using standard peri-procedural noninvasive blood pressure monitoring at predefined time points.
|
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
Временное ограничение: 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 was measured in millimeters of mercury (mmHg) using standard peri-procedural noninvasive blood pressure monitoring at predefined time points.
|
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
Временное ограничение: 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 was measured in millimeters of mercury (mmHg) using standard peri-procedural noninvasive blood pressure monitoring at predefined time points.
|
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)
Временное ограничение: 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 was measured as a percentage (%) using standard peri-procedural pulse oximetry monitoring at predefined time points.
|
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.
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Gülten Arslan, MD, University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
17 июля 2024 г.
Первичное завершение (Действительный)
31 декабря 2025 г.
Завершение исследования (Действительный)
31 декабря 2025 г.
Даты регистрации исследования
Первый отправленный
6 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
12 мая 2026 г.
Первый опубликованный (Действительный)
19 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
19 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- DLKTRH-AVR-CEDB-02
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Individual participant data (IPD) will not be shared due to ethical and confidentiality concerns.
The dataset contains sensitive patient information, and participants did not provide consent for public data sharing.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .