Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT

Официальное название

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

Обзор

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.

Подробное описание

Electroconvulsive therapy (ECT) requires general anesthesia and neuromuscular blockade to prevent musculoskeletal injuries during induced seizures. However, systemic paralysis masks the motor seizure activity, which is the primary indicator of an adequate seizure. The gold standard for seizure monitoring is the Isolated Forearm Technique (IFT), which involves applying a high-pressure arterial tourniquet (\>250 mmHg) before muscle relaxant administration. While effective, IFT can cause ischemic pain, sympathetic activation (hypertension, tachycardia), and requires specialized equipment.

This study investigates an alternative approach using a within-subject design. After systemic neuromuscular blockade (rocuronium 0.6 mg/kg) is established, an arterial tourniquet is applied to one arm (control limb), while a standard venous tourniquet (70 mmHg) is applied to the contralateral arm (experimental limb) followed by a regional IV injection of low-dose (0.3 mg/kg) sugammadex. This localized reversal aims to restore muscle function solely in the isolated limb. By evaluating both methods simultaneously on the same patient, the study eliminates inter-individual biological variability, allowing for a highly reliable comparison of motor seizure visibility, duration, and local complication rates between the arterial and venous tourniquet methods.

Вмешательства

• Устройство Device: 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.
• Устройство Device: 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.
• Препарат Sugammadex
  Regional IV injection of 0.3 mg/kg sugammadex into the experimental limb.

Первичные конечные точки

• Motor Seizure Duration [Срок оценки: 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.]

Вторичные конечные точки (4)

• Patient Pain Score (Numeric Rating Scale - NRS) [Срок оценки: At exactly 30 minutes after the completion of the ECT procedure in the recovery room.]
• Hemodynamic Changes: Heart Rate [Срок оценки: 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.]
• Hemodynamic Changes: Mean Arterial Pressure (MAP) [Срок оценки: 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.]
• Incidence of Local Tourniquet Complications [Срок оценки: At 1 hour after the completion of the ECT procedure, before discharge from the recovery area.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Medipol University — Istanbul

Идентификаторы

NCT: NCT07534475 · 273 2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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