RecruitingNot ApplicableNCT07534475

Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT

Comparison of Venous Tourniquet Method With Isolated Forearm Technique in Electroconvulsive Therapy in Terms of Efficacy and Safety


Sponsor

Medipol University

Enrollment

20 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • Patients scheduled for elective Electroconvulsive Therapy (ECT).
  • ASA (American Society of Anesthesiologists) physical status I to III.

Exclusion Criteria4

  • 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.

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Interventions

DEVICEDevice: Arterial Tourniquet

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.

DEVICEDevice: Venous Tourniquet

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.

DRUGSugammadex

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


Locations(1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

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NCT07534475


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