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Completed

NCT Number: NCT02761239

Innervation of Human Cricopharyngeal Muscle By Recurrent Laryngeal and External Branch of Superior Laryngeal Nerve

The investigators hypothesized that, external branch of the superior laryngeal nerve (EBSLN) and/or recurrent laryngeal nerve (RLN) contribute to the motor function of the human cricopharyngeal muscle (CP). The investigators aimed to assess the contribution of the laryngeal nerves (EBSLN and RLN) to the motor activity of the cricopharyngeal muscle, during thyroidectomy with intraoperative neuromonitoring (IONM).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study group consisted of a consecutive patients undergoing thyroid surgery with intraoperative neuromonitoring (NIM 3.0 Nerve Monitoring Systeme (Medtronic Xomed, Jacksonville, FL, USA) ) for various diseases. In all patients, each side of the neck operated was considered as a separate entity in our study.

EMG recordings were accomplished with a pair of needle electrodes inserted into the CP and mid-portion of the CT muscle that is located on the superior side of the RLN, which were plugged into the third and fourth channels of interface-connector box, respectively, at the end of the thyroidectomy or lobectomy. The investigators evaluated the innervation pattern of the CT muscle in an other study. Therefore the EBSLN is the main supplier of the CT muscle, the EMG findings of the CT muscle were used to confirm it, in this study.

EBSLN, pharyngeal plexus (PP), RLN and vagus nerve were stimulated with a monopolar stimulator probe at 1 mA. While stimulating these nerves, the ipsilateral CP muscle was visually observed for possible contractions and electromyographic recordings were obtained with the 4-channel NIM 3.0 Nerve Monitoring System.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patients who underwent thyroidectomy.

Exclusion criteria

  • Preoperative RLN palsy
  • Thyroid cancer with massive extrathyroidal extension
  • Intentional nerve transection because of cancer invasion
  • The assessment failure of nerve function due to the technical deficiency of the IONM equipment

Treatment and study plan

The NIM 3.0 Nerve Monitoring System

Device

Electromyography recordings were accomplished with a pair of needle electrodes inserted through the CP muscle, which were plugged into the third and fourth channels of interface-connector box.The recurrent laryngeal nerve(RLN), vagus nerve, external branch of the superior laryngeal nerve(EBSLN) and pharyngeal plexus were stimulated with a current of 1 mA and a frequency of 4 MHz and the event threshold at 100 microV.

Primary outcomes

  1. The cricopharyngeal muscle innervation pattern that is evaluated by visual contractions and EMG evoked potentials, with stimulation of the nerves

    Time frame: up to 9 months

Secondary outcomes

  1. The comparison of the EMG amplitudes obtained with the stimulation of the recurrent laryngeal nerve (RLN), vagus nerve, external branch of the superior laryngeal nerve (EBSLN) and pharyngeal plexus.

    Time frame: up to 9 months

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

Descriptive In Vivo Study of Evaluating the Innervation of The Human Cricopharyngeal Muscle By The Recurrent Laryngeal Nerve and External Branch of The Superior Laryngeal Nerve

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 4, 2016
Registry last updated
May 4, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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