Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

12. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Turecko (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turecko (Türkiye)
        • Kartal Dr. Lütfi Kırdar City Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Propofol Group
Participants in this group received propofol 1.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
Lék: Propofol group
Propofol administered intravenously at a dose of 1.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Ostatní jména:
  • Propofol-PF
Experimentální: Thiopenthal Group
Participants in this group received thiopental 3 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
Lék: Thiopental
Thiopental administered intravenously at a dose of 3 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Ostatní jména:
  • Pental Sodyum
  • Thiopental Sodium
Experimentální: Ketamine Group
Participants in this group received ketamine 0.5 mg/kg intravenously for anesthesia induction prior to electroconvulsive therapy (ECT).
Lék: Ketamine (0.5 mg/kg)
Ketamine administered intravenously at a dose of 0.5 mg/kg for anesthesia induction prior to electroconvulsive therapy.
Ostatní jména:
  • Ketalar
Experimentální: 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).
Lék: 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.
Ostatní jména:
  • Ketamine-propofol combination

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
EEG Seizure Duration
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Heart Rate
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

17. července 2024

Primární dokončení (Aktuální)

31. prosince 2025

Dokončení studie (Aktuální)

31. prosince 2025

Termíny zápisu do studia

První předloženo

6. května 2026

První předloženo, které splnilo kritéria kontroly kvality

12. května 2026

První zveřejněno (Aktuální)

19. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • DLKTRH-AVR-CEDB-02

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Propofol group

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Paraguay

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit