Clinical trial NCT06754995: Diagnostic Feasibility of 100 Hz Tetanic Stimulation
Official title: Diagnostic Feasibility of 100 Hz Tetanic Stimulation in the Perioperative Setting in Patients With Normal and Abnormal ENG: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polyneuropathies
Keywords: electromyography
electroneurography
tetanic stimulation
residual neuromuscular block
neuromuscular monitoring
Lead sponsor: University of Debrecen
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients

Brief summary: 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.

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

Primary outcomes:
measure: 100 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG
timeFrame: From enrollment until end of anesthesia asessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
Secondary outcomes:
measure: Diagnostic feasibility of electromyography in the examination of safety margin
timeFrame: From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
Other outcomes:
measure: 60 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG
timeFrame: From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
Locations:
city: Debrecen
country: Hungary
facility: Department of Anesthesiology and Intensive Care, University of Debrecen
state: Hajdú-Bihar
city: Debrecen
country: Hungary
facility: University of Debrecen Medical Center, Department of Anesthesiology and Intensive Care
Study officials:
affiliation: University of Debrecen
name: Béla Fülesdi, MD PhD DSci
role: STUDY_DIRECTOR
References: