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Effect of Topical Anesthesia on the Phonation Process During High-Speed Digital Imaging Laryngoscopy in Patients With Laryngopharyngeal Reflux
Sponsor: Mario Bilić
Summary
The goal of this clinical trial is to learn if topical anesthesia (lidocaine spray) affects the phonation process during High-Speed Digital Imaging (HSDI) laryngoscopy in adults with laryngopharyngeal reflux (LPR). The main questions it aims to answer are: Does topical anesthesia change phonation process parameters (such as mucosal wave amplitude, glottal closure pattern, phase symmetry, and periodicity) as assessed on the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form? Does topical anesthesia change the type of glottal insufficiency observed during phonation? Researchers will compare HSDI recordings performed with topical anesthesia (lidocaine spray) to recordings performed with placebo (physiological saline) to see if topical anesthesia alters phonation process findings. Participants will: Undergo HSDI laryngoscopy recording on two consecutive days, once with topical anesthesia and once with placebo, in a randomized, double-blind order Have a detailed medical history taken and complete the Reflux Symptom Index (RSI) questionnaire Undergo fiberendoscopic examination for determination of the Reflux Finding Score (RFS) Return for a follow-up examination within three months, during which they will continue proton pump inhibitor therapy and hygienic-dietary measures
Official title: The Effect of Topical Anesthesia on the Phonation Process During High-Speed Digital Imaging Laryngoscopy in Patients With Laryngopharyngeal Reflux: A Randomized Double-Blind Placebo-Controlled Crossover Study
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2019-03-01
Completion Date
2021-12-05
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
Lidocaine 10% Spray
Lidocaine spray, 100 mg/ml, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment.
Placebo
Physiological saline (0.9% NaCl) spray, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment, identical in application technique to the lidocaine intervention.
Locations (1)
University Hospital Centre Zagreb (KBC Zagreb), Department of ORL Head and Neck Surgery
Zagreb, Croatia