NCT05436743

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

December 16, 2021

Last Update Submit

June 28, 2022

Conditions

Postoperative Sore Throat

Outcome Measures

Primary Outcomes (1)

  • Postoperative sore throat

    Postoperative sore throat

    up to 6 hours postoperatively

Study Arms (2)

K-Y jelly soaked packs

EXPERIMENTAL

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

Drug: K-Y Jelly, Topical Gel soaked packs

Water soaked packs

ACTIVE COMPARATOR

Water soaked packs inserted for pretension of postoperative sore throat

Other: Water soaked packs

Interventions

K-Y Jelly, Topical Gel soaked packsDRUG

Topical Gel used as lubricant

K-Y jelly soaked packs
Water soaked packsOTHER

Water soaked packs for reduction of postoperative sore throat

Water soaked packs

Eligibility Criteria

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

You may qualify if:

  • Patients submitted to nasal surgery under general anesthesia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

K-Y jelly

Study Officials

  • Ahmed Algarhy

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Algarhy, PhD

CONTACT

0 111 088 8332Elgarhy_79@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 16, 2021

First Posted

June 29, 2022

Study Start

July 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

June 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)