Diagnostic Feasibility of 100 Hz Tetanic Stimulation

NCT06754995 | Recruiting

• 1 other identifier: AITT 2024/2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Polyneuropathies

Keywords

electromyography; electroneurography; tetanic stimulation; residual neuromuscular block; neuromuscular monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnostic feasibility of electromyography in the examination of safety margin

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

Other Outcomes (1)

• 60 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG

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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients

You may qualify if:

• ASA 1-3;
• BMI 18.5-25 (normal body weight);
• patient is in supine position with one arm accessible.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (2)

Department of Anesthesiology and Intensive Care, University of Debrecen

Debrecen, Hajdú-Bihar, 4032, Hungary

NOT YET RECRUITING

University of Debrecen Medical Center, Department of Anesthesiology and Intensive Care

Debrecen, 4032, Hungary

RECRUITING

MeSH Terms

Conditions

Polyneuropathies; Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Béla Fülesdi, MD PhD DSci

  University of Debrecen

  STUDY DIRECTOR

Central Study Contacts

Adrienn Pongrácz, MD PhD

CONTACT

+36302390132; pongadri@gmail.com

Réka Nemes, MD PhD

CONTACT

+36309668722; reka.nemes.11@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 1, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2)