An observational study in Polyneuropathies, sponsored by University of Debrecen. Recruiting at 2 sites in Hungary. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by University of Debrecen · Observational
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.
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:
133 studies on the registry are indexed under Polyneuropathies; 33 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 53 observational studies indexed under Polyneuropathies.
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Surgical patients
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have normal results at baseline electroneurogrphy examination
Patients who have abnormal results at baseline electroneurogrphy examination due to polyneuropathy
100 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG
Electroneurography response of the abductor digiti minimi muscle to 100 Hz tetanic stimulation (tetanic fade) is examined to find out if there is difference in patients with or without polyneuropathy. Tetanic fade is the decrease of the twitch heights of the compound muscle action potential due to depletion of cetylcholin stores in the nerve terminal during tetanic stimulation.
Time frame: From enrollment until end of anesthesia asessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
Diagnostic feasibility of electromyography in the examination of safety margin
To see whether tetanic stimulation with electromyography can be used as a routine tool to examine the safety margin and residual neuromuscular block. It is expected that there will be no fade in muscle response to 60 Hz tetanic stimulation in either groups. It is suspected that there will be no tetanic fade response to 100 Hz tetanic stimulation in patinets with normal ENG, however patinets with abnormal baseline ENG will produce tetanic fade. The incidence and extent of tetanic fade response will be examined.
Time frame: From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
60 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG
Electroneurography response of the abductor digiti minimi muscle to 60 Hz tetanic stimulation (tetanic fade) is examined to find out if there is difference in patients with or without polyneuropathy. Tetanic fade is the decrease of the twitch heights of the compound muscle action potential due to depletion of cetylcholin stores in the nerve terminal during tetanic stimulation.
Time frame: From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.
Plan to share: No
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University of Debrecen