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

12. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
    • Istanbul
      • Istanbul, Istanbul, Türkei (türkiye)
        • Kartal Dr. Lütfi Kırdar City Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Propofol Group
Participants in this group received propofol 1.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
Arzneimittel: Propofol group
Propofol administered intravenously at a dose of 1.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Andere Namen:
  • Propofol-PF
Experimental: Thiopenthal Group
Participants in this group received thiopental 3 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
Arzneimittel: Thiopental
Thiopental administered intravenously at a dose of 3 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Andere Namen:
  • Pental Sodyum
  • Thiopental Sodium
Experimental: Ketamine Group
Participants in this group received ketamine 0.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
Arzneimittel: Ketamine (0.5 mg/kg)
Ketamine administered intravenously at a dose of 0.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Andere Namen:
  • Ketalar
Experimental: 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).
Arzneimittel: Ketofol
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.
Andere Namen:
  • Ketamine-propofol combination

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
EEG Seizure Duration
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
From the end of ECT stimulation until achievement of Modified Aldrete Score ≥9, assessed up to 30 minutes after ECT.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Heart Rate
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Ermittler

  • Hauptermittler: Gülten Arslan, MD, University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. Juli 2024

Primärer Abschluss (Tatsächlich)

31. Dezember 2025

Studienabschluss (Tatsächlich)

31. Dezember 2025

Studienanmeldedaten

Zuerst eingereicht

6. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DLKTRH-AVR-CEDB-02

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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