Diagnostic Feasibility of 100 Hz Tetanic Stimulation

NCT ID: NCT06754995

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-06

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Polyneuropathies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal ENG

Patients who have normal results at baseline electroneurogrphy examination

No interventions assigned to this group

Abnormal ENG

Patients who have abnormal results at baseline electroneurogrphy examination due to polyneuropathy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Debrecen

OTHER

Sponsor Role lead

Responsible Party

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Pongrácz Adrienn

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Béla Fülesdi, MD PhD DSci

Role: STUDY_DIRECTOR

University of Debrecen

Locations

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Department of Anesthesiology and Intensive Care, University of Debrecen

Debrecen, Hajdú-Bihar, Hungary

Site Status NOT_YET_RECRUITING

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

Debrecen, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Adrienn Pongrácz, MD PhD

Role: CONTACT

+36302390132

Réka Nemes, MD PhD

Role: CONTACT

+36309668722

Facility Contacts

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Adrienn Pongrácz, MD PhD

Role: primary

+36302390132

Réka Nemes, MD PhD

Role: backup

+36309668722

Other Identifiers

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AITT 2024/2

Identifier Type: -

Identifier Source: org_study_id

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