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COMPLETED
NCT07710365

Individualized Supramaximal Stimulation Current During Continuous Neuromonitoring in Thyroid Surgery

Sponsor: Medical University of Gdansk

View on ClinicalTrials.gov

Summary

Continuous intraoperative neuromonitoring (C-IONM) is increasingly used during thyroid surgery to detect early changes in recurrent laryngeal nerve function and reduce the risk of nerve injury. Current clinical practice recommends the use of fixed supramaximal stimulation currents; however, these recommendations are based on limited experimental evidence and may not account for individual variability between patients. This retrospective observational cohort study aims to determine patient-specific supramaximal stimulation currents (SSC) during C-IONM and to evaluate whether individualized stimulation provides monitoring quality comparable to conventional fixed-current stimulation while potentially reducing unnecessary stimulation intensity. The study also investigates factors influencing electromyographic response amplitudes during surgery and assesses the safety of individualized stimulation parameters.

Official title: Patient-Specific Determination of Supramaximal Stimulation Current During Continuous Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

623

Start Date

2020-06-18

Completion Date

2025-02-11

Last Updated

2026-07-17

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Continuous intraoperative neuromonitoring with fixed stimulation current

Continuous vagus nerve stimulation during thyroid surgery using a fixed supramaximal stimulation current of 1.5 mA.

PROCEDURE

Continuous intraoperative neuromonitoring with individualized stimulation current

Continuous vagus nerve stimulation during thyroid surgery using an individually determined supramaximal stimulation current established at the beginning of the procedure.

Locations (1)

The University Clinical Centre in Gdansk

Gdansk, Poland