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

Larynx Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761239
• Other study ID #: SEEAH02
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: May 1, 2016
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: Sisli Etfal Training & Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Larynx

Intervention

Device:
• The NIM 3.0 Nerve Monitoring System
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Etfal Training & Research Hospital

References & Publications (7)

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. — View Citation

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. — View Citation

Mu L, Sanders I. Neuromuscular specializations within human pharyngeal constrictor muscles. Ann Otol Rhinol Laryngol. 2007 Aug;116(8):604-17. — View Citation

Mu L, Sanders I. The innervation of the human upper esophageal sphincter. Dysphagia. 1996 Fall;11(4):234-8. — View Citation

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. — View Citation

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.morp — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cricopharyngeal muscle innervation pattern that is evaluated by visual contractions and EMG evoked potentials, with stimulation of the nerves		up to 9 months	Yes
Secondary	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	Yes