Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT

Sponsor
Medipol University
Study ID
NCT07534475
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Apr 16, 2026
Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
May 30, 2026
Completion
Jun 20, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: All ECT Patients
    All enrolled patients will receive both interventions simultaneously. An arterial tourniquet will be applied to one limb (control), and a venous tourniquet followed by regional sugammadex will be applied to the contralateral limb (experimental) during the same ECT session.

Primary Outcome Measure

Motor Seizure Duration [ 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. ]

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