NCT04214938

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

2.2 years

First QC Date

December 23, 2019

Last Update Submit

December 30, 2019

Conditions

Nasopharyngeal Diseases

Keywords

hypertonic saline solutionslidocaineoxymetazolineisotonic salinediscomfort

Outcome Measures

Primary Outcomes (1)

  • Quality of view, ease of procedure

    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)

    2 years

Secondary Outcomes (2)

  • Post-op pain

    2 years

  • Post-op discomfort

    2 years

Study Arms (4)

Hypertonic sea water

ACTIVE COMPARATOR

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

Lidocaine

ACTIVE COMPARATOR

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

Xylometazoline

ACTIVE COMPARATOR

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

0.9% Sodium chloride

PLACEBO COMPARATOR

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

Interventions

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

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.

Also known as: 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)
0.9% Sodium chlorideHypertonic sea waterLidocaineXylometazoline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who undergone diagnostic nasal endoscopy between 2015- 2017

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nasopharyngeal Diseases

Interventions

halofantrine

Condition Hierarchy (Ancestors)

Pharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ozkan Onal, Professor

    Selcuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The caregiver administering the nasal spray, the subject, and the otolaryngologist carrying out nasendoscopy were all uninformed as to the type of spray employed.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A Double Blind, Randomized, Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 23, 2019

First Posted

January 2, 2020

Study Start

February 1, 2016

Primary Completion

May 1, 2018

Study Completion

January 1, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12