Major Depressive DisorderNCT07534475
Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT
A study testing Device: Arterial Tourniquet, Device: Venous Tourniquet and Sugammadex in people with Major Depressive Disorder and Bipolar Disorder, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- What is being tested?
- Device: Arterial Tourniquet, Device: Venous Tourniquet and Sugammadex
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective Electroconvulsive Therapy (ECT).
- ASA (American Society of Anesthesiologists) physical status I to III.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul
Burak Ömür, +905056215056, bomur@medipol.edu.tr
About this study
Official title: 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.
Read the 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
- Being tested
- Device: Arterial Tourniquet, Device: Venous Tourniquet, Sugammadex
- Keywords
- Electroconvulsive Therapy, Isolated Forearm Technique, Sugammadex, Neuromuscular Blockade, Seizure Monitoring, Tourniquet
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
SugammadexDrug
Regional IV injection of 0.3 mg/kg sugammadex into the experimental limb.
| Study group | Role | What they receive |
|---|---|---|
| All ECT Patients | Experimental | 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. Receives: Device: Device: Arterial Tourniquet; Device: Device: Venous Tourniquet; Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 1 hour after the completion of the ECT procedure, before discharge from the recovery area.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Apr 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Omur, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534475
- Sponsor's protocol ID
- 273 2026
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Venous Tourniquet Method With Isolated Forearm Technique in Electroconvulsive Therapy in Terms of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT07534475
- Acronym / sponsor ID
- 273 2026
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- Keywords
- Electroconvulsive Therapy, Isolated Forearm Technique, Sugammadex, Neuromuscular Blockade, Seizure Monitoring, Tourniquet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All ECT Patients | Experimental | Device: Device: Arterial Tourniquet, Device: Device: Venous Tourniquet, Drug: SugammadexAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective Electroconvulsive Therapy (ECT).
- ASA (American Society of Anesthesiologists) physical status I to III.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Arterial TourniquetWithin 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 | All ECT Patients |
| Device: Venous TourniquetWithin 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. | Device | All ECT Patients |
| SugammadexRegional IV injection of 0.3 mg/kg sugammadex into the experimental limb. | Drug | All ECT Patients |
Primary outcome
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.
4 secondary outcomes
Patient Pain Score (Numeric Rating Scale - NRS)
Time frame: At exactly 30 minutes after the completion of the ECT procedure in the recovery room.
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.
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.
Incidence of Local Tourniquet Complications
Time frame: At 1 hour after the completion of the ECT procedure, before discharge from the recovery area.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Arterial Tourniquet, Device: Venous Tourniquet and Sugammadex in people with Major Depressive Disorder and Bipolar Disorder, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.