Postoperative Sore ThroatPhase 4NCT05436743
Efficacy of K-Y Jelly in Prevention of Postoperative Sore Throat After Nasal Surgery
A Phase 4 study testing K-Y Jelly, Topical Gel soaked packs and Water soaked packs in people with Postoperative Sore Throat, run by Alaa Gamal at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- K-Y Jelly, Topical Gel soaked packs and Water soaked packs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients submitted to nasal surgery under general anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University Hospitals
Cairo
Ahmed Algarhy, PhD
About this study
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.
Read the 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.
- Conditions
- Postoperative Sore Throat
- Being tested
- K-Y Jelly, Topical Gel soaked packs, Water soaked packs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-Y Jelly, Topical Gel soaked packsDrug
Topical Gel used as lubricant
Water soaked packsOther
Water soaked packs for reduction of postoperative sore throat
| Study group | Role | What they receive |
|---|---|---|
| K-Y jelly soaked packs | Experimental | K-Y jelly soaked packs inserted for pretension of postoperative sore throat Receives: Drug: K-Y Jelly, Topical Gel soaked packs |
| Water soaked packs | Active comparator | Water soaked packs inserted for pretension of postoperative sore throat Receives: Other: Water soaked packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative sore throat
Postoperative sore throat
Measured: up to 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa Gamal
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Alaa Gamal, Egyptian Biomedical Research Network
- Investigators
- Ahmed Algarhy, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436743
- Sponsor's protocol ID
- 072021
- Status last verified
- Jun 2022
- First submitted
- 16 Dec 2021
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of K-Y Jelly in Prevention of Postoperative Sore Throat After Nasal Surgery
- ClinicalTrials.gov ID
- NCT05436743
- Acronym / sponsor ID
- 072021
- Conditions
- Postoperative Sore Throat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Alaa GamalResearch network
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K-Y jelly soaked packs | Experimental | Drug: K-Y Jelly, Topical Gel soaked packsK-Y jelly soaked packs inserted for pretension of postoperative sore throat |
| Water soaked packs | Active comparator | Other: Water soaked packsWater soaked packs inserted for pretension of postoperative sore throat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients submitted to nasal surgery under general anesthesia.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-Y Jelly, Topical Gel soaked packsTopical Gel used as lubricant | Drug | K-Y jelly soaked packs |
| Water soaked packsWater soaked packs for reduction of postoperative sore throat | Other | Water soaked packs |
Primary outcome
Postoperative sore throat
Time frame: up to 6 hours postoperatively
Postoperative sore throat
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Algarhy principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing K-Y Jelly, Topical Gel soaked packs and Water soaked packs in people with Postoperative Sore Throat, run by Alaa Gamal at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Algarhy, PhD (0 111 088 8332 ext. 0020, Elgarhy_79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative sore throat (time frame: up to 6 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.