Bipolar Disorder, Major Depressive Disorder, Schizophrenia
Conditions
Keywords
Electroconvulsive Therapy, Isolated Forearm Technique, Sugammadex, Neuromuscular Blockade, Seizure Monitoring, Tourniquet
Brief 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). 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.
Interventions
DEVICEDevice: 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.
DEVICEDevice: 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.
DRUGSugammadex
Regional IV injection of 0.3 mg/kg sugammadex into the experimental limb.
Sponsors
Medipol University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Score (Numeric Rating Scale - NRS) | 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). |
| 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. | Measurement of Heart Rate (beats per minute) to assess the systemic sympathetic response to tourniquet inflation and potential ischemic pain. |
| 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. | Measurement of Mean Arterial Pressure (mmHg) to assess the systemic sympathetic response to tourniquet inflation and potential ischemic pain. |
| Incidence of Local Tourniquet Complications | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed