Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT

Conditions studied

Major Depressive Disorder, Bipolar Disorder, Schizophrenia

About this study

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.

Interventions

• 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.
• Drug: Sugammadex — Regional IV injection of 0.3 mg/kg sugammadex into the experimental limb.

Primary outcomes

• Motor Seizure Duration (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.)

Eligibility information

Study locations

• Istanbul Medipol University, Istanbul, Turkey (Türkiye)