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Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later May 30, 2026 → Nov 30, 2026
See other at-risk trials from Medipol University

Record History

  1. Notable Primary completion pushed from May 30, 2026 to Nov 30, 2026 Recruitment opened · Completion pushed from Jun 20, 2026 to Dec 20, 2026 · Site details revisedv3 Show 3 more changesShow less
    • Recruitment opened
    • Completion pushed from Jun 20, 2026 to Dec 20, 2026
    • Site details revised
  2. Minor Trial arms changed: 2 → 1 Interventions: Device: Arterial Tourniquet (Device), Device: Venous Tourniquet (Device) to Device: Arterial Tourniquet (Device), Device: Venous Tourniquet (Device), Sugammadex (Drug)v2 Show 1 more changeShow less
    • Interventions: Device: Arterial Tourniquet (Device), Device: Venous Tourniquet (Device) to Device: Arterial Tourniquet (Device), Device: Venous Tourniquet (Device), Sugammadex (Drug)
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07534475
Lead Sponsor Medipol University
Conditions Major Depressive Disorder, Bipolar Disorder, Schizophrenia
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov