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
About this trial
This is an interventional prevention trial for Postoperative Sore Throat
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.
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
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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