Efficacy of K-Y Jelly in Prevention of Postoperative Sore Throat After Nasal Surgery

NCT ID: NCT05436743

Last Updated: 2022-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-08-31

Brief Summary

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Postoperative sore throat (POST) is a fairly common side effect of general anesthesia which is caused by the mucosal injury and nerve compression associated with tracheal intubation or laryngeal mask airway device insertion. In this randomized study, the authors evaluate the effect of K-Y jelly-soaked nasopharyngeal packs on POST and postoperative nausea and vomiting in patients subjected to nasal surgery.

Detailed Description

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Postoperative sore throat (POST) is a fairly common side effect of general anesthesia which is caused by the mucosal injury and nerve compression associated with tracheal intubation or laryngeal mask airway device insertion. In this randomized study, the authors evaluate the effect of K-Y jelly-soaked nasopharyngeal packs on POST and postoperative nausea and vomiting in patients subjected to nasal surgery.

The present double-blinded randomized controlled study was conducted at Al-Azhar University Hospitals, Cairo, Egypt. The study protocol was approved by the local ethical committee of Al-Azhar Faculty of Medicine and all patients provided informed consent before enrollment in the study.

Conditions

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Postoperative Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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K-Y jelly soaked packs

K-Y jelly soaked packs inserted for pretension of postoperative sore throat

Group Type EXPERIMENTAL

K-Y Jelly, Topical Gel soaked packs

Intervention Type DRUG

Topical Gel used as lubricant

Water soaked packs

Water soaked packs inserted for pretension of postoperative sore throat

Group Type ACTIVE_COMPARATOR

Water soaked packs

Intervention Type OTHER

Water soaked packs for reduction of postoperative sore throat

Interventions

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K-Y Jelly, Topical Gel soaked packs

Topical Gel used as lubricant

Intervention Type DRUG

Water soaked packs

Water soaked packs for reduction of postoperative sore throat

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients submitted to nasal surgery under general anesthesia.

Exclusion Criteria

* Acute of chronic nasopharyngeal conditions,
* Gastroesophageal reflux, regurgitation,
* History of postoperative sore throat,
* nasal surgery for malignant disease,
* concurrent or recent use of systemic or topical agents used for sore throat or
* Mallampati grade more than 2.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alaa Gamal

NETWORK

Sponsor Role lead

Responsible Party

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Alaa Gamal

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed Algarhy

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

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Al-Azhar University Hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Algarhy, PhD

Role: CONTACT

0 111 088 8332 ext. 0020

Facility Contacts

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Ahmed Algarhy, PhD

Role: primary

Other Identifiers

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072021

Identifier Type: -

Identifier Source: org_study_id

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