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

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02761239
• Collaborator: (none)
• Enrollment: 100
• Arm: 1
• Duration (Months): 9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Larynx	Device: The NIM 3.0 Nerve Monitoring System	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Other: Cricopharyngeal muscle innervation 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; 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital

Investigators

• Study Director: Mehmet Uludag, Professor, Sisli Etfal Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Mehmet Uludag, Associated Professor, Sisli Hamidiye Etfal Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT02761239
• Other Study ID Numbers: SEEAH02
• First Posted: May 4, 2016
• Last Update Posted: May 4, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mehmet Uludag, Associated Professor, Sisli Hamidiye Etfal Training and Research Hospital: cricopharyngeal muscle; innervation by EBSLN; A prospective case-controlled study

Study Results

No Results Posted as of May 4, 2016