Identification of Nerves Using Fluorescein Sodium

Stanford University8 enrolled

Overview

The purpose of this study is to see if there is benefit in using an IV contrast (sodium fluorescein) to identify nerves during head and neck surgery.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pleomorphic Adenoma of the Parotid Warthin Tumor Head and Neck Disorder Head and Neck Thyroid Disease Thyroidectomy

Interventions

Fluorescein SodiumDRUG

Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female subjects 2. 18 years or older 3. Scheduled for open head and neck surgery Exclusion Criteria: 1. Inability or unwillingness of a subject 2. Pregnancy 3. Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students) 4. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study 5. History of adverse reaction to fluorescein including allergy. 6. History of renal failure or chronic kidney disease

Locations (1)

Stanford Medical Center

Palo Alto, California, United States

Outcomes

Primary Outcomes

Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation

Surgeon assessment of fluorescence correlation with electrostimulation using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation

Time frame: Intraoperative (day 1, up to 1 minute to assess)

Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve

Survey of surgeon visual assessment of nerve under white light compared to fluorescence using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.

Time frame: Intraoperative (day 1, up to 1 minute to assess)

Ratio of Nerve Fluorescence Compared to Background Tissue

Weber contrast ratio of nerve fluorescence intensity compared to background fluorescence intensity

Time frame: Intraoperative (Day 1, Up to 20 minutes to assess)

Secondary Outcomes

Average Dose of Sodium Fluorescein Administration

Average dose of sodium fluorescein administered in mg/kg

Time frame: Intraoperative (day 1)

Time to Nerve Visualization

Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration

Time frame: Intraoperative (day 1, up to approximately 200 minutes for initial imaging)

Data from ClinicalTrials.gov

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