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NCT Number: NCT07534475

Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Burak Ömür

CONTACT

[email protected]

+905056215056

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Device: Arterial Tourniquet

Device

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: Venous Tourniquet

Device

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.

Sugammadex

Drug

Regional IV injection of 0.3 mg/kg sugammadex into the experimental limb.

Primary outcomes

  1. Motor Seizure Duration

    Time frame: 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.

Secondary outcomes

  1. Patient Pain Score (Numeric Rating Scale - NRS)

    Time frame: At exactly 30 minutes after the completion of the ECT procedure in the recovery room.

    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).

  2. Hemodynamic Changes: Heart Rate

    Time frame: 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.

    Measurement of Heart Rate (beats per minute) to assess the systemic sympathetic response to tourniquet inflation and potential ischemic pain.

  3. Hemodynamic Changes: Mean Arterial Pressure (MAP)

    Time frame: 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.

    Measurement of Mean Arterial Pressure (mmHg) to assess the systemic sympathetic response to tourniquet inflation and potential ischemic pain.

  4. Incidence of Local Tourniquet Complications

    Time frame: At 1 hour after the completion of the ECT procedure, before discharge from the recovery area.

    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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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