Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve During Thyroid Surgery

Seoul National University

Status: Terminated

Conditions: Carcinoma, Papillary, Follicular

Treatments: Device: Using Neuromonitoring to find EBSLN

Study type: Interventional

Funder types: Other

Identifiers

NCT03773120

1708-125-880

Details and patient eligibility

About

The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.

Full description

The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality. Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from 10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%, depending on different evaluation methods. Advances in intraoperative neuromonitoring techniques would allow for EBSLN identification during thyroid surgery. However, there is controversy regarding usefulness in preserving EBSLN function using nerve monitoring system. The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of EBSLNs.

Enrollment: 5 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• planned open thyroidectomy
• acceptable clinical laboratory tests
• understand clinical trials
• no significant past medical history

Exclusion criteria

• planned radical neck dissection
• hyperthyroidism history
• history of laryngeal nerve palsy
• laryngeal disease history
• uncontrolled hypertension or diabetes mellitus or heart disease
• anticoagulation or antiplatelet medication
• stroke history
• participated another clinical trials in 30days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

Using Neuromonitoring to find EBSLN

Experimental group

Description:

With Neuromonitoring of the EBSLN using nerve monitoring system

Treatment:

Device: Using Neuromonitoring to find EBSLN

No Using Neuromonitoring to find EBSLN

No Intervention group

Description:

Without Neuromonitoring of the EBSLN using nerve monitoring system