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Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT

ConditionsMajor Depressive DisorderBipolar DisorderSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedipol University

About this trial

This prospective, open-label clinical trial aims to compare a novel "Venous Tourniquet with Regional Low-Dose Sugammadex" method against the gold standard "Arterial Tourniquet" (Isolated Forearm Technique - IFT) for monitoring motor seizure activity during Electroconvulsive Therapy (ECT). Using a within-subject (intra-individual) design, each of the 40 enrolled patients will receive an arterial tourniquet on one arm and a venous tourniquet on the other arm simultaneously. The study will evaluate clinical efficacy in observing motor seizures, comparing the duration and visibility between the two limbs of the same patient, as well as assessing overall patient comfort and hemodynamics.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective Electroconvulsive Therapy (ECT).

ASA (American Society of Anesthesiologists) physical status I to III.

Disqualifiers

Known neuromuscular diseases (e.g., Myasthenia Gravis).

Known allergy or hypersensitivity to sugammadex, rocuronium, ketamine, dexmedetomidine, or propofol.

Presence of venous insufficiency, lymphedema, or active infection in the upper extremities.

Severe cardiovascular instability.

Trial design

Design model

Single group

Treatments tested in this trial

  • Device: Arterial Tourniquet

    Device

    Within the same patient, the arm without intravenous access is fitted with an arterial tourniquet (\>250 mmHg or 100 mmHg above systolic BP) before the systemic administration of 0.6 mg/kg rocuronium.

  • Device: Venous Tourniquet

    Device

    Within the same patient, the arm with intravenous access receives a venous tourniquet (elastic or 70 mmHg) after systemic rocuronium administration, followed by a regional IV injection of 0.3 mg/kg sugammadex (diluted in 20 ml saline) into that specific limb.

  • Sugammadex

    Drug

    Regional IV injection of 0.3 mg/kg sugammadex into the experimental limb.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: All ECT PatientsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Motor Seizure Duration

The duration of visible tonic-clonic motor seizure activity observed in both the arterial tourniquet limb and the venous tourniquet limb. It will be recorded in seconds.

Time frame
From the initiation of the ECT electrical stimulus until the complete cessation of visible motor seizure activity in the limbs, assessed up to a maximum of 5 minutes.

Secondary outcomes

1

Patient Pain Score (Numeric Rating Scale - NRS)

Assessment of tourniquet-induced pain in both procedural arms. Pain will be measured using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable". A higher score indicates a worse outcome (more severe pain).

Time frame
At exactly 30 minutes after the completion of the ECT procedure in the recovery room.
2

Hemodynamic Changes: Heart Rate

Measurement of Heart Rate (beats per minute) to assess the systemic sympathetic response to tourniquet inflation and potential ischemic pain.

Time frame
Evaluated at 3 specific time points: Baseline (1 minute prior to anesthesia induction), exactly 2 minutes after tourniquet inflation, and 1 minute after the cessation of the ECT motor seizure.
3

Hemodynamic Changes: Mean Arterial Pressure (MAP)

Measurement of Mean Arterial Pressure (mmHg) to assess the systemic sympathetic response to tourniquet inflation and potential ischemic pain.

Time frame
Evaluated at 3 specific time points: Baseline (1 minute prior to anesthesia induction), exactly 2 minutes after tourniquet inflation, and 1 minute after the cessation of the ECT motor seizure.
4

Incidence of Local Tourniquet Complications

The number of participants experiencing any visible local skin complications (such as petechiae, ecchymosis) or reporting signs of nerve compression/neuropraxia (numbness, tingling) at either of the tourniquet application sites.

Time frame
At 1 hour after the completion of the ECT procedure, before discharge from the recovery area.

Other outcomes

Sponsors and contacts

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Medipol University

Lead sponsor

Source ClinicalTrials.gov
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