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NCT Number: NCT06754995

Diagnostic Feasibility of 100 Hz Tetanic Stimulation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care, University of Debrecen, Debrecen, Hajdú-Bihar, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  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.

    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.

Other outcomes

  1. 60 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 assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adrienn Pongrácz, MD PhD

CONTACT

[email protected]

+36302390132

Réka Nemes, MD PhD

CONTACT

[email protected]

+36309668722

Sponsors and collaborators

Lead sponsor

University of Debrecen

Other

Registry information

Official study title

Diagnostic Feasibility of 100 Hz Tetanic Stimulation in the Perioperative Setting in Patients With Normal and Abnormal ENG: a Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 1, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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