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临床试验/NCT07534475
NCT07534475招募中不适用

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

Medipol University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年4月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Motor Seizure Duration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

All ECT Patients

Experimental

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.

干预措施: Device: Arterial Tourniquet (Device)

All ECT Patients

Experimental

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.

干预措施: Device: Venous Tourniquet (Device)

All ECT Patients

Experimental

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.

干预措施: Sugammadex (Drug)

结局指标

主要结局

Motor Seizure Duration

时间窗: 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.

The duration of visible tonic-clonic motor seizure activity observed in both the arterial tourniquet limb and the venous tourniquet limb. It will be recorded in seconds.

次要结局

  • Patient Pain Score (Numeric Rating Scale - NRS)(At exactly 30 minutes after the completion of the ECT procedure in the recovery room.)
  • Hemodynamic Changes: Heart Rate(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)(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(At 1 hour after the completion of the ECT procedure, before discharge from the recovery area.)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burak Omur

Assistant Professor

Medipol University

研究点 (1)

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