NCT07534475

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This prospective, single-blind 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.

Detailed description

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.

Conditions

• Major Depressive Disorder
• Bipolar Disorder
• Schizophrenia

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-05-30
• Completion: 2026-06-20
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Turkey (Türkiye)