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Demedetomidine and Remifentanil in Electroconvulsive Therapy (ECT)

ConditionHemodynamic Response
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInonu University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,

Patients scheduled for six ECT sessions for a variety of psychiatric conditions

Disqualifiers

refusal to participate,

age below 18 or above 60 years

pregnancy

asthma

Trial design

Design model

Crossover

Treatments tested in this trial

  • Saline (0.9% NaCl)

    Drug

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

  • Dexmedetomidine

    Drug

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

  • Remifentanil

    Drug

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

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Control group (Group C)Placebo comparator 1 intervention
Group B: Dexmedetomidine group (Group D)Active comparator 1 intervention
Group C: Remifentanil group (Group R)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hemodynamic response

Arterial blood pressure will be recorded at the following times.

Time frame
Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.

Secondary outcomes

1

seizure duration

After anesthesia induction patients will administered electrical stimulation and seizure duration will measured.

Time frame
up to ten minutes after electrical stimulation
2

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

The time from the end of muscle relaxant administration to the recovery of spontaneous breathing, eye opening, and obeying of verbal commands were recorded.

Time frame
After seizure in one hour in operation room

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inonu University

Lead sponsor

Source ClinicalTrials.gov
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