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

NCT ID: NCT04214938

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2019-01-01

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.

Conditions

Nasopharyngeal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Hypertonic sea water

The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure.

Group Type: ACTIVE_COMPARATOR

Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

Intervention Type: OTHER

Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.

Lidocaine

The patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure.

Group Type: ACTIVE_COMPARATOR

Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

Intervention Type: OTHER

Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.

Xylometazoline

The patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure.

Group Type: ACTIVE_COMPARATOR

Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

Intervention Type: OTHER

Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.

0.9% Sodium chloride

The patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure.

Group Type: PLACEBO_COMPARATOR

Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

Intervention Type: OTHER

Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.

Interventions

Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.

Intervention Type: OTHER

Other Intervention Names

intranasal hypertonic sea water (Ancient Secrets, USA); intranasal lidocaine (Vemcaine AstraZeneca, Södertälje, Sweden); intranasal xylometazoline (Otrivine, GlaxoSmithKline, Brentford, UK); intranasal isotonic saline (Deva, Istanbul, TR)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Merih Onal

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ozkan Onal, Professor

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Other Identifiers

15.01.2015

Identifier Type: -

Identifier Source: org_study_id