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

Sponsor

Selcuk University (Other)

Overall Status

Completed

CT.gov ID

NCT04214938

Collaborator

(none)

200

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Diseases	Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Double Blind, Randomized, Controlled TrialA Double Blind, Randomized, Controlled Trial

Masking:

Double (Participant, Investigator)

Masking Description:

The caregiver administering the nasal spray, the subject, and the otolaryngologist carrying out nasendoscopy were all uninformed as to the type of spray employed.

Primary Purpose:

Other

Official Title:

Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures: A Double Blind, Randomized, Controlled Trial Comparing the Efficacy of Intranasal Hypertonic Saline, Xylometazoline, Lidocaine, and Isotonic Saline

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hypertonic sea water The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure.	Other: 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. Other 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)
Active Comparator: Lidocaine The patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure.	Other: 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. Other 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)
Active Comparator: Xylometazoline The patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure.	Other: 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. Other 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)
Placebo Comparator: 0.9% Sodium chloride The patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure.	Other: 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. Other 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)

Outcome Measures

Primary Outcome Measures

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

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.