Demedetomidine and Remifentanil in Electroconvulsive Therapy (ECT)

NCT07824817 | Recruiting Phase 4

• 1 other identifier: ECT and dexmedetomidine
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemodynamic Response

Keywords

Electroconvulsive therapy

Outcome Measures

Primary Outcomes (1)

• Hemodynamic response

  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.

Secondary Outcomes (2)

• seizure duration

  up to ten minutes after electrical stimulation

• Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands

  After seizure in one hour in operation room

Study Arms (3)

Control group (Group C)

PLACEBO COMPARATOR

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

Drug: Saline (0.9% NaCl)

Dexmedetomidine group (Group D)

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Remifentanil group (Group R)

ACTIVE COMPARATOR

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

Drug: Remifentanil

Interventions

Saline (0.9% NaCl) DRUG

Saline will infused over 10 minutes (total volume: 30 mL)

Control group (Group C)

Dexmedetomidine DRUG

Dexmedetomidine at a dose of 0.5 μg/kg will infused over 10 minutes (total volume: 30 mL)

Dexmedetomidine group (Group D)

Remifentanil DRUG

Remifentanil at a dose of 1 μg/kg will infused over 10 minutes (total 30 ml)

Remifentanil group (Group R)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu Universitesi Turgut Ozal Tıp Merkezi

Malatya, Battalgazi, 44210, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Durmus I, Sezen O, Cevik B, Altintas M. Comparison of the Effects of Dexmedetomidine and Remifentanil on Seizure Duration, Hemodynamics, and Recovery Time in Electroconvulsive Therapy. J ECT. 2026 Jun 1;42(2):119-124. doi: 10.1097/YCT.0000000000001161. Epub 2026 May 27.

  PMID: 40424541 RESULT

MeSH Terms

Interventions

Sodium Chloride; Dexmedetomidine; Remifentanil

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• zekine begeç, Prof.Dr

  STUDY DIRECTOR

Central Study Contacts

Zekine Begeç, Prof.Dr

CONTACT

904223410660; zekine.begec@inonu.edu.tr

ülkü özgül, prof. dr

CONTACT

904223410660; ulku.ozgul@inonu.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study medications will be prepared by an anesthesiologist who is not involved in patient management or data collection. The study drugs will be prepared in the same volume and administered at the same rate. Neither the anesthesiologist nor the patient will know which drug is being administered
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 17, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)