Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures

Phase 4

Completed

• Conditions: Nasopharyngeal Diseases
• Interventions: Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

• Registration Number: NCT04214938
• Lead Sponsor: Selcuk University

Brief Summary

Transnasal Flexible Pharyngolaryngoscopy (NPL) is one of the most common and fundamental evaluation procedures in otolaryngologist's practice, performed in both outpatient and ward settings.In the studies the desired properties for an effective topical agent to be used in patients undergoing NPL. To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain. However, to date, no studies have been performed in which intranasal hypertonic saline was used prior to nasal endoscopy.

Detailed Description

NPL is a technique that has been used for more than 100 years and increases brightness, magnification and the ability to take still and video images (3). NPL is a simple, safe, cost-effective, and generally well-tolerated procedure. However, a portion of patients may refuse to allow the procedure to be repeated as they find it uncomfortable, intolerable, or painful.To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain and increase the field of view and to reduce the duration of examination and unpleasant sensations for the patient on NPL procedures.This randomised control trial was undertaken to compare the application of nasal hypertonic sea water (3.5%) with nasal lidocaine 10%, topical nasal decongestant xylometazoline 0.1% (OtrivineTM) and nasal isotonic serum physiologic as placebo group in relation to how they effectively improve the adequacy of the examination and if they reduce pain and discomfort associated with endoscopic nasal examination.

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2018-05-01
• Study Completion: 2019-01-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subjects who undergone diagnostic nasal endoscopy between 2015- 2017

Exclusion Criteria

• Had experienced nasal endoscopy before
• Pregnant
• Allergic to either xylometazoline or lidocaine
• Asthma
• Cardiovascular disease
• Rhinitis
• Severe septal deviation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% Sodium chloride	Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization	The patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure.
Hypertonic sea water	Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization	The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure.
Xylometazoline	Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization	The patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure.
Lidocaine	Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization	The patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure.

Primary Outcome Measures

Name	Time	Method
Quality of view, ease of procedure	2 years	The primary outcome was to evaluate clinicians' field of the view according to Visual Analog Scale (VAS) questionnaire survey. Shortly after endoscopy, the endoscopist was asked to indicate the degree of quality of view, ease of procedure on a VAS (1: impossible to pass the endoscope, 100: excellent field of view)

Secondary Outcome Measures

Name	Time	Method
Post-op pain	2 years	The secondary outcome was to evaluate the patients' pain after the naso-endoscopy procedure according to Visual Analog Scale (VAS) questionnaire survey. Shortly after endoscopy, subjects were asked to indicate their degree of pain on a VAS (1: no pain, 100: unbearable pain).
Post-op discomfort	2 years	The secondary outcome was to evaluate the patients' discomfort after the nasoendoscopy procedure according to Visual Analog Scale (VAS) questionnaire survey. Shortly after spraying each bottle, subjects were asked to indicate their degree of discomfort on a visual analogue scale (VAS) (1: no discomfort, 100: utmost discomfort). For each spray, one independent scores were obtained from each subject.