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Completed

NCT Number: NCT07596095

Induction Agents in ECT: Effects on Seizure Duration, Quality, and Recovery

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.

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Key information

Conditions

Electroconvulsive Therapy Anesthesia, General

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol group

Drug

Propofol administered intravenously at a dose of 1.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.

Other names: Propofol-PF

Thiopental

Drug

Thiopental administered intravenously at a dose of 3 mg/kg for anesthesia induction prior to electroconvulsive therapy.

Other names: Pental Sodyum, Thiopental Sodium

Ketamine (0.5 mg/kg)

Drug

Ketamine administered intravenously at a dose of 0.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.

Other names: Ketalar

Ketofol

Drug

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.

Other names: Ketamine-propofol combination

Primary outcomes

  1. EEG Seizure Duration

    Time frame: 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.

  2. Postictal Suppression Index

    Time frame: 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.

  3. Recovery time

    Time frame: 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

Secondary outcomes

  1. Heart Rate

    Time frame: 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.

  2. Patient State Index (PSI)

    Time frame: 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.

  3. Incidence of Post-procedural Complications

    Time frame: 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.

  4. Mean Arterial Pressure

    Time frame: 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.

  5. Systolic Arterial Pressure

    Time frame: 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.

  6. Diastolic Arterial Pressure

    Time frame: 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.

  7. Peripheral Oxygen Saturation (SpO₂)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

The Effects of Induction Agents Applied During Electroconvulsive Therapy on Seizure Duration, Seizure Quality, and Recovery Time

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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