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

June 28, 2022 updated by: Alaa Gamal
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Al-Azhar University Hospitals
        • Contact:
          • Ahmed Algarhy, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: K-Y jelly soaked packs
K-Y jelly soaked packs inserted for pretension of postoperative sore throat
Drug: K-Y Jelly, Topical Gel soaked packs
Topical Gel used as lubricant
Active Comparator: Water soaked packs
Water soaked packs inserted for pretension of postoperative sore throat
Other: Water soaked packs
Water soaked packs for reduction of postoperative sore throat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative sore throat
Time Frame: up to 6 hours postoperatively
Postoperative sore throat
up to 6 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaa Gamal

Investigators

  • Principal Investigator: Ahmed Algarhy, Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

December 16, 2021

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 072021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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