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

Primary Purpose

Postoperative Sore Throat

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
K-Y Jelly, Topical Gel soaked packs
Water soaked packs
Sponsored by
Alaa Gamal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Sore Throat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Al-Azhar University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

K-Y jelly soaked packs

Water soaked packs

Arm Description

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

Water soaked packs inserted for pretension of postoperative sore throat

Outcomes

Primary Outcome Measures

Postoperative sore throat
Postoperative sore throat

Secondary Outcome Measures

Full Information

First Posted
December 16, 2021
Last Updated
June 28, 2022
Sponsor
Alaa Gamal
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1. Study Identification

Unique Protocol Identification Number
NCT05436743
Brief Title
Efficacy of K-Y Jelly in Prevention of Postoperative Sore Throat After Nasal Surgery
Official Title
Efficacy of K-Y Jelly in Prevention of Postoperative Sore Throat After Nasal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alaa Gamal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Sore Throat

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
K-Y jelly soaked packs
Arm Type
Experimental
Arm Description
K-Y jelly soaked packs inserted for pretension of postoperative sore throat
Arm Title
Water soaked packs
Arm Type
Active Comparator
Arm Description
Water soaked packs inserted for pretension of postoperative sore throat
Intervention Type
Drug
Intervention Name(s)
K-Y Jelly, Topical Gel soaked packs
Intervention Description
Topical Gel used as lubricant
Intervention Type
Other
Intervention Name(s)
Water soaked packs
Intervention Description
Water soaked packs for reduction of postoperative sore throat
Primary Outcome Measure Information:
Title
Postoperative sore throat
Description
Postoperative sore throat
Time Frame
up to 6 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Algarhy, PhD
Phone
0 111 088 8332
Ext
0020
Email
Elgarhy_79@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Algarhy
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Azhar University Hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Algarhy, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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