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

NCT07596095 | Completed

• 1 other identifier: DLKTRH-AVR-CEDB-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Electroconvulsive Therapy; Anesthesia, General

Keywords

seizure duration; seizure quality; induction agents; Anesthesia; ECT; Propofol; thiopental; Ketamine; Ketofol; Postictal Suppression Index; Patient State Index; SedLine; Recovery Time; Electroconvulsive Therapy; Hemodynamic Parameters

Outcome Measures

Primary Outcomes (3)

• EEG Seizure Duration

  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

  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

  Time to Modified Aldrete Score ≥9

  From the end of ECT stimulation until achievement of Modified Aldrete Score ≥9, assessed up to 30 minutes after ECT.

Secondary Outcomes (7)

• 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.

Study Arms (4)

Propofol Group

EXPERIMENTAL

Participants in this group received propofol 1.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).

Drug: Propofol group

Thiopenthal Group

EXPERIMENTAL

Participants in this group received thiopental 3 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).

Drug: Thiopental

Ketamine Group

EXPERIMENTAL

Participants in this group received ketamine 0.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).

Drug: Ketamine (0.5 mg/kg)

Ketofol Group

EXPERIMENTAL

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).

Drug: Ketofol

Interventions

Propofol group DRUG

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

Also known as: Propofol-PF

Propofol Group

Thiopental DRUG

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

Also known as: Pental Sodyum, Thiopental Sodium

Thiopenthal Group

Ketamine (0.5 mg/kg) DRUG

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

Also known as: Ketalar

Ketamine Group

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.

Also known as: Ketamine-propofol combination

Ketofol Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Thiopental; Ketamine

Intervention Hierarchy (Ancestors)

Thiobarbiturates; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gülten Arslan, MD

  University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident Physician (Anesthesiology)

Model Details: This is a randomized, parallel-group study in which participants are allocated to one of four groups receiving different anesthetic induction agents during electroconvulsive therapy (ECT). Each participant receives a single assigned intervention, and outcomes are compared between groups.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 19, 2026
• Study Start: July 17, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)