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

NCT02761239 | Completed

• 1 other identifier: SEEAH02
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Larynx

Keywords

cricopharyngeal muscle; innervation by EBSLN; A prospective case-controlled study

Outcome Measures

Primary Outcomes (1)

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

  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.

  up to 9 months

Study Arms (1)

Cricopharyngeal muscle innervation

OTHER

The recurrent laryngeal nerve (RLN), vagus nerve, external branch of the superior laryngeal nerve (EBSLN) and pharyngeal plexus were stimulated intraoperatively by the NIM 3.0 Nerve Monitoring System (Medtronic Xomed, Jacksonville, FL, USA). Responses were evaluated by visual observation of the cricopharyngeal muscle and electromyographies via needle electrodes inserted into the cricopharyngeal muscle.

Device: The NIM 3.0 Nerve Monitoring System

Interventions

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.

Cricopharyngeal muscle innervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients who underwent thyroidectomy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Related Publications (7)

• Mu L, Sanders I. Neuromuscular specializations within human pharyngeal constrictor muscles. Ann Otol Rhinol Laryngol. 2007 Aug;116(8):604-17. doi: 10.1177/000348940711600809.

  PMID: 17847729 BACKGROUND

• Sasaki CT, Kim YH, Sims HS, Czibulka A. Motor innervation of the human cricopharyngeus muscle. Ann Otol Rhinol Laryngol. 1999 Dec;108(12):1132-9. doi: 10.1177/000348949910801207.

  PMID: 10605917 BACKGROUND

• Brok HA, Copper MP, Stroeve RJ, Ongerboer de Visser BW, Venker-van Haagen AJ, Schouwenburg PF. Evidence for recurrent laryngeal nerve contribution in motor innervation of the human cricopharyngeal muscle. Laryngoscope. 1999 May;109(5):705-8. doi: 10.1097/00005537-199905000-00005.

  PMID: 10334217 BACKGROUND

• Halum SL, Shemirani NL, Merati AL, Jaradeh S, Toohill RJ. Electromyography findings of the cricopharyngeus in association with ipsilateral pharyngeal and laryngeal muscles. Ann Otol Rhinol Laryngol. 2006 Apr;115(4):312-6. doi: 10.1177/000348940611500411.

  PMID: 16676829 BACKGROUND

• Oezcelik A, DeMeester SR. General anatomy of the esophagus. Thorac Surg Clin. 2011 May;21(2):289-97, x. doi: 10.1016/j.thorsurg.2011.01.003.

  PMID: 21477778 RESULT

• Mu L, Sanders I. The innervation of the human upper esophageal sphincter. Dysphagia. 1996 Fall;11(4):234-8. doi: 10.1007/BF00265207.

  PMID: 8870349 RESULT

• Prades JM, Timoshenko AP, Asanau A, Gavid M, Benakki H, Dubois MD, Faye MB, Martin C. [The cricopharyngeal muscle and the laryngeal nerves: contribution to the functional anatomy of swallowing]. Morphologie. 2009 Aug-Sep;93(301):35-41. doi: 10.1016/j.morpho.2009.07.001. Epub 2009 Oct 7. French.

  PMID: 19815444 RESULT

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Mehmet Uludag, Professor

  Sisli Etfal Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: May 4, 2016
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 4, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share