Demedetomidine and Remifentanil in Electroconvulsive Therapy (ECT)

September 11, 2026 updated by: 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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
Drug: Saline (0.9% NaCl)
Saline will infused over 10 minutes (total volume: 30 mL)
Active Comparator: 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
Drug: Dexmedetomidine
Dexmedetomidine at a dose of 0.5 μg/kg will infused over 10 minutes (total volume: 30 mL)
Active Comparator: 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
Drug: Remifentanil
Remifentanil at a dose of 1 μg/kg will infused over 10 minutes (total 30 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic response
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seizure duration
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Study Director: zekine begeç, Prof.Dr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 21, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECT and dexmedetomidine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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