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Demedetomidine and Remifentanil in Electroconvulsive Therapy (ECT)

11 septembre 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

24

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: 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
Médicament: Saline (0.9% NaCl)
Saline will infused over 10 minutes (total volume: 30 mL)
Comparateur actif: 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
Médicament: Dexmedetomidine
Dexmedetomidine at a dose of 0.5 μg/kg will infused over 10 minutes (total volume: 30 mL)
Comparateur actif: 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
Médicament: Remifentanil
Remifentanil at a dose of 1 μg/kg will infused over 10 minutes (total 30 ml)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Hemodynamic response
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
seizure duration
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Inonu University

Les enquêteurs

  • Directeur d'études: zekine begeç, Prof.Dr

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

21 septembre 2026

Achèvement primaire (Estimé)

1 février 2027

Achèvement de l'étude (Estimé)

15 avril 2027

Dates d'inscription aux études

Première soumission

3 septembre 2026

Première soumission répondant aux critères de contrôle qualité

11 septembre 2026

Première publication (Réel)

17 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ECT and dexmedetomidine

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

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