NCT07534475

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Major Depressive DisorderBipolar DisorderSchizophrenia

Keywords

Electroconvulsive TherapyIsolated Forearm TechniqueSugammadexNeuromuscular BlockadeSeizure MonitoringTourniquet

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

Study Arms (2)

Control Limb: Arterial Tourniquet

ACTIVE COMPARATOR
Device: Device: Arterial Tourniquet

Experimental Limb: Venous Tourniquet + Regional Sugammadex

EXPERIMENTAL
Device: Device: Venous Tourniquet

Interventions

Device: Arterial TourniquetDEVICE

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.

Control Limb: Arterial Tourniquet
Device: Venous TourniquetDEVICE

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.

Experimental Limb: Venous Tourniquet + Regional Sugammadex

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 20, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)