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Demedetomidine and Remifentanil in Electroconvulsive Therapy (ECT)

11. september 2026 oppdatert av: Zekine Begec, Inonu University

Comparison of Three Different Anesthetic Methods in ECT

Electroconvulsive therapy (ECT) is a treatment modality that induces therapeutic seizures through electrical stimulation for the management of certain psychiatric disorders. Nearly all ECT procedures are performed under general anesthesia. However, ECT is commonly associated with acute hyperdynamic responses immediately following electrical stimulation, including transient hypertension and tachycardia. These acute hemodynamic changes may pose significant risks, particularly in patients with ischemic heart disease, hypertension, or cerebrovascular disease. Therefore, the hemodynamic response, seizure quality, and recovery profile are critical factors influencing the choice of anesthetic and adjuvant agents. The primary goal of anesthesia for ECT is to maintain hemodynamic stability without compromising seizure duration or quality while ensuring rapid and safe recovery

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Various pharmacological agents have been investigated in the Electroconvulsive therapy (ECT) procedures. Dexmedetomidine, widely used for sedation, attenuates stress-induced sympathoadrenal responses, reduces postoperative agitation, improves intraoperative hemodynamic stability, and decreases anesthetic requirements during a variety of surgical procedures. As an α2-adrenergic receptor agonist, dexmedetomidine has been shown to attenuate the hyperdynamic response associated with ECT. Remifentanil is a potent μ-opioid receptor agonist characterized by its rapid onset and ultra-short duration of action due to rapid metabolism and elimination. An additional advantage of opioid agonists is their ability to suppress sympathetic responses without increasing the seizure threshold. Consequently, short-acting opioid analgesics such as remifentanil have been recommended as adjuncts during ECT because they improve hemodynamic stability, facilitate rapid recovery, and may prolong seizure duration.

Both dexmedetomidine and remifentanil have been widely used for sedation in anesthesia practice for many years, and several studies have evaluated their use during ECT . Furthermore, the prescribing information for both agents indicates that they are approved for sedation in operating rooms and intensive care units.

The primary objective of this study is to compare the effects of dexmedetomidine and remifentanil on the hemodynamic response in patients undergoing ECT. The secondary objectives are to evaluate seizure duration and recovery characteristics. We anticipate that the findings of this study will contribute to the identification of a safer and more effective anesthetic approach for patients undergoing ECT.

Studietype

Intervensjonell

Registrering (Antatt)

24

Fase

  • Fase 4

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,
  • Patients scheduled for six ECT sessions for a variety of psychiatric conditions

Exclusion Criteria:

  • refusal to participate,
  • age below 18 or above 60 years
  • pregnancy
  • asthma
  • current use of β-adrenergic blockers
  • myocardial infarction within the previous six months
  • atrial fibrillation or atrial flutter,
  • heart block
  • a known personal or family history of hypersensitivity to any of the study drugs

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Control group (Group C)
Whereas patients in the control group (Group C) will receive normal saline infused over 10 minutes (total volume: 30 mL). Immediately after completion of saline infusion, anesthesia will be induced with propofol at a dose of 1 mg/kg in Group C. If an adequate depth of anesthesia is not achieved, as determined by failure to respond to verbal commands and loss of the eyelash reflex, supplemental propofol will be administered in 10 mg increments at 10-second intervals until adequate anesthesia is achieved. The total propofol dose administered will be recorded. Following loss of consciousness, rocuronium 0.3 mg/kg will be administered intravenously to all patients to achieve muscle relaxation, after which patients will be ventilated with 100% oxygen for 90 seconds. A suprathreshold electrical stimulus will then be delivered using the ECT device
Legemiddel: Saline (0.9% NaCl)
Saline will infused over 10 minutes (total volume: 30 mL)
Aktiv komparator: Dexmedetomidine group (Group D)
Patients in the dexmedetomidine group (Group D) will receive intravenous dexmedetomidine at a dose of 0.5 μg/kg infused over 10 minutes (total volume: 30 mL). Immediately after completion of the study drug infusion, anesthesia will be induced with propofol at a dose of 1 mg/kg. If an adequate depth of anesthesia is not achieved, as determined by failure to respond to verbal commands and loss of the eyelash reflex, supplemental propofol will be administered in 10 mg increments at 10-second intervals until adequate anesthesia is achieved. The total propofol dose administered will be recorded. Following loss of consciousness, rocuronium 0.3 mg/kg will be administered intravenously to all patients to achieve muscle relaxation, after which patients will be ventilated with 100% oxygen for 90 seconds. A suprathreshold electrical stimulus will then be delivered using the ECT device
Legemiddel: Dexmedetomidine
Dexmedetomidine at a dose of 0.5 μg/kg will infused over 10 minutes (total volume: 30 mL)
Aktiv komparator: Remifentanil group (Group R)
Patients in the remifentanil group (Group R) will receive intravenous remifentanil at a dose of 1 μg/kg infused over 10 minutes (total volume: 30 mL).Immediately after completion of the study drug infusion, anesthesia will be induced with propofol at a dose of 1 mg/kg. If an adequate depth of anesthesia is not achieved, as determined by failure to respond to verbal commands and loss of the eyelash reflex, supplemental propofol will be administered in 10 mg increments at 10-second intervals until adequate anesthesia is achieved. The total propofol dose administered will be recorded. Following loss of consciousness, rocuronium 0.3 mg/kg will be administered intravenously to all patients to achieve muscle relaxation, after which patients will be ventilated with 100% oxygen for 90 seconds. A suprathreshold electrical stimulus will then be delivered using the ECT device
Legemiddel: Remifentanil
Remifentanil at a dose of 1 μg/kg will infused over 10 minutes (total 30 ml)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hemodynamic response
Tidsramme: Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.
Arterial blood pressure will be recorded at the following times.
Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
seizure duration
Tidsramme: up to ten minutes after electrical stimulation
After anesthesia induction patients will administered electrical stimulation and seizure duration will measured.
up to ten minutes after electrical stimulation
Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands
Tidsramme: After seizure in one hour in operation room
The time from the end of muscle relaxant administration to the recovery of spontaneous breathing, eye opening, and obeying of verbal commands were recorded.
After seizure in one hour in operation room

Samarbeidspartnere og etterforskere

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Sponsor

Inonu University

Etterforskere

  • Studieleder: zekine begeç, Prof.Dr

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

21. september 2026

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

15. april 2027

Datoer for studieregistrering

Først innsendt

3. september 2026

Først innsendt som oppfylte QC-kriteriene

11. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ECT and dexmedetomidine

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Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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