Diagnostic Feasibility of 100 Hz Tetanic Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Polyneuropathies. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diagnostic Feasibility of 100 Hz Tetanic Stimulation in the Perioperative Setting in Patients With Normal and Abnormal ENG: a Pilot Study
Overview
The goal of this observational study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography device in the exclusion of postoperative residual neuromuscular block. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings.
Detailed description
The aim of the present study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography (EMG) device. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings. Electric responses of the musculus digiti minimi elicited by supramaximal stimulation of the ulnar nerve at the carpal tunnel are monitored. Alpine Biomed ENG-EMG device with Keypoint software version 5.11 is used for the examinations. The exposed arm is fixed on the armboard, the skin is degreased and then the electrodes for monitoring are mounted lege artis. After the anesthesia has been induced, ENG of the ulnar nerve is examined. Based on the results of the ENG test, patients are divided into separate groups (normal or abnormal ENG). During the ENG test, the supramaximal current is determined. Afterwards, repetitive tetanic stimulation of the defined frequency (60 and 100 Hz) and duration (5 sec) is applied to the two test groups at the current according to the test plan.
The clinical utilities of the study results are:
* Determination of the "safety margin" of neuromuscular junction, which is not provided by routine monitoring. * To investigate how comorbid status (especially chronic conditions affecting peripheral nerves such as polyneuropathy) influences the feasibility of tetanic stimulation in the diagnostics of residual neuromuscular block and safety margin.
Primary outcome measures
- 100 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG [Time frame: From enrollment until end of anesthesia asessed up to 1 hour. No further ENG measurements are performed in the postoperative period.]
Secondary outcome measures (1)
- Diagnostic feasibility of electromyography in the examination of safety margin [Time frame: From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.]
Eligibility criteria
Inclusion criteria
- ASA 1-3;
- BMI 18.5-25 (normal body weight);
- patient is in supine position with one arm accessible.
Exclusion criteria
- diseases with impaired neuromuscular function (myopathies, severe liver and kidney failure);
- drugs affecting neuromuscular function (magnesium, aminoglycosides);
- pregnancy (pregnancy tests are carried out in women of childbearing age to rule out pregnancy);
- breast-feeding;
- acute surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Hungary · 2 centers
- Department of Anesthesiology and Intensive Care, University of Debrecen — Debrecen
- University of Debrecen Medical Center, Department of Anesthesiology and Intensive Care — Debrecen
Identifiers
NCT: NCT06754995 · AITT 2024/2