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Demedetomidine and Remifentanil in Electroconvulsive Therapy (ECT)

Comparison of Three Different Anesthetic Methods in ECT

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07824817
Enrollment
24
Registered
2026-09-17
Start date
2026-09-21
Completion date
2027-04-15
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Response

Keywords

Electroconvulsive therapy

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

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.

Interventions

DRUGSaline (0.9% NaCl)

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

DRUGDexmedetomidine

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

DRUGRemifentanil

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

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hemodynamic responseBefore 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.

Secondary

MeasureTime frameDescription
seizure durationup to ten minutes after electrical stimulationAfter anesthesia induction patients will administered electrical stimulation and seizure duration will measured.
Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commandsAfter seizure in one hour in operation roomThe time from the end of muscle relaxant administration to the recovery of spontaneous breathing, eye opening, and obeying of verbal commands were recorded.

Contacts

CONTACTZekine Begeç, Prof.Dr
zekine.begec@inonu.edu.tr904223410660
CONTACTülkü özgül, prof. dr
ulku.ozgul@inonu.edu.tr904223410660
STUDY_DIRECTORzekine begeç, Prof.Dr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026