Clinical Trial

Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT

Recruiting
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Summary
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.
Protocol Amendment History 4 changes
critical Recruitment opened 2026-07-28
notable Primary completion pushed: 2026-05-30 -> 2026-11-30 2026-07-28
minor Completion pushed: 2026-06-20 -> 2026-12-20 2026-07-28
minor Trial arms changed: 2 -> 1 2026-04-22
Trial Details
NCT Number NCT07534475
Lead Sponsor Medipol University
Conditions Major Depressive Disorder, Bipolar Disorder, Schizophrenia
Enrollment 20 participants
Start Date 2026-04-20
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-12-20 (estimated)
Updated on ClinicalTrials.gov 2026-07-27