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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia; Bipolar Disorder; Major Depressive Disorder
• Intervention / Treatment: Device: Device: Arterial Tourniquet; Device: Device: Venous Tourniquet; Drug: Sugammadex

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • İstanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All ECT Patients; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Seizure Duration	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Pain Score (Numeric Rating Scale - NRS)	Assessment of tourniquet-induced pain in both procedural arms. Pain will be measured using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable". A higher score indicates a worse outcome (more severe pain).	At exactly 30 minutes after the completion of the ECT procedure in the recovery room.
Hemodynamic Changes: Heart Rate	Measurement of Heart Rate (beats per minute) to assess the systemic sympathetic response to tourniquet inflation and potential ischemic pain.	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)	Measurement of Mean Arterial Pressure (mmHg) to assess the systemic sympathetic response to tourniquet inflation and potential ischemic pain.	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	The number of participants experiencing any visible local skin complications (such as petechiae, ecchymosis) or reporting signs of nerve compression/neuropraxia (numbness, tingling) at either of the tourniquet application sites.	At 1 hour after the completion of the ECT procedure, before discharge from the recovery area.

Collaborators and Investigators

• Sponsor: Medipol University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Electroconvulsive Therapy; Tourniquet; Neuromuscular Blockade; Sugammadex; Isolated Forearm Technique; Seizure Monitoring
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Mood Disorders; Depressive Disorder; Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Carbohydrates; Polycyclic Compounds; Polysaccharides; Macrocyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Dextrins; Starch; Glucans; Sugammadex
• Other Study ID Numbers: 273 2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No