Investigation of Human Laryngeal Evoked Brainstem Potentials

Not Applicable

Completed

• Conditions: Thyroidectomy

• Registration Number: NCT02803359
• Lead Sponsor: NYU Langone Health

Brief Summary

The primary purpose of this study will be to determine whether the proposed study protocol will allow for reliable detection of the human Laryngeal evoked brainstem responses (LEBR). Laryngeal evoked brain stem responses will be recorded from five test subjects under general anesthesia in the operating room with the assistance of an electrophysiologist with expertise in evoked potentials. Once the feasibility of obtaining tracings are established on the first few subjects, responses will be recorded from other test subjects with the aim of determining the optimal placement of stimulating electrodes and detection leads necessary to elicit an adequate response. The effect of varying the stimulus intensity will also be studied. Once parameters for testing have been standardized, normative configurations for the laryngeal evoked brainstem response tracings can be determined by patients both in the office setting and in the operating room.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Primary Completion: 2020-07-28
• Study Completion: 2020-07-28
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Healthy Subjects undergoing thyroid or other open neck surgeries

Exclusion Criteria

• Current or recent (within one month) tracheostomy
• Vocal cord paralysis
• History of Stroke
• History of Diabetes Mellitus
• History of Neurologic Disease
• History of Radiation to the Neck
• History of Brain Surgery
• History of Neck Surgery
• Recent Laryngeal Surgery (within one month)
• Recent Intubation (within two weeks)
• Laryngopharyngeal Reflux Disease
• Allergy to Lidocaine
• Allergy to Oxymetazoline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
analysis of variance in brain auditory evoked response (BAER) measured using recording electroencephalography electrodes	One Year	Distributions of latencies within this group will be examined to evaluate the appropriateness of standard assumptions regarding normality and constant variance, and transformations or non-parametric statistics will be considered as needed.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States