Diagnostic Feasibility of 100 Hz Tetanic Stimulation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Polyneuropathies

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Adrienn Pongrácz, MD PhD; Phone Number: +36302390132; Email: pongadri@gmail.com
• Study Contact Backup: Name: Réka Nemes, MD PhD; Phone Number: +36309668722; Email: reka.nemes.11@gmail.com

Study Locations

• Hungary
  • Debrecen, Hungary, 4032
    • Recruiting
    • University of Debrecen Medical Center, Department of Anesthesiology and Intensive Care
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Not yet recruiting
      • Department of Anesthesiology and Intensive Care, University of Debrecen
      • Contact: Adrienn Pongrácz, MD PhD; Phone Number: +36302390132; Email: pongadri@gmail.com
      • Contact: Réka Nemes, MD PhD; Phone Number: +36309668722; Email: reka.nemes.11@gmail.com
      • Contact: Mariann Fedor, MD
      • Contact: Adrienn Pongrácz, MD PhD
      • Contact: Réka Nemes, MD PhD
      • Contact: László Asztalos, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Surgical patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Normal ENG; Patients who have normal results at baseline electroneurogrphy examination
Abnormal ENG; Patients who have abnormal results at baseline electroneurogrphy examination due to polyneuropathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment until end of anesthesia asessed up to 1 hour. No further ENG measurements are performed in the postoperative period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.

Collaborators and Investigators

• Sponsor: University of Debrecen
• Investigators: Study Director: Béla Fülesdi, MD PhD DSci, University of Debrecen

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: electromyography; electroneurography; neuromuscular monitoring; tetanic stimulation; residual neuromuscular block
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies
• Other Study ID Numbers: AITT 2024/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No