Postoperative Sore ThroatPhase 2/3postNCT06266481
Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce POST in Shoulder Arthroscopic Surgeries: A Comparative Study
A Phase 2/3 study testing Topical dexamethasone and 10% lidocaine was sprayed over the tube for the second group in people with Postoperative Sore Throat, run by Pharos University in Alexandria at 1 site in Egypt.
Trial summary
postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- Topical dexamethasone and 10% lidocaine was sprayed over the tube for the second group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 30 May 2024
- Phase
- Phase 2/3
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- •Patients belonging to ASA physical status I, II
- Patients between age18 to 50 years
- Patients belonging to both genders.
- patients undergoing shoulder arthroscopic surgeries.
- Patients with fasting blood glucose \<100 mg/dl or random blood sugar \<140 mg/dl.
Who cannot join
- Patients who are not willing to give consent for participation in the study
- Patients with anticipated difficult airway
- Patients who are allergic to steroids.
- Patients with ASA physical status III, IV
- Diabetic patients.
- Patients on steroids
Show all 11Show fewer
- Patients requiring nasogastric tube or throat pack.
- Patients posted for head and neck surgeries.
- patient with GERD
- Pregnant patients
- preexisting upper respiratory tract infection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Pharos University
Alexandria, 21348
mona el. massoud, ph anesthesia, 002+01005542232, mona.elsaid@pua.edu.eg
hatem a. attalla, ph anaesthesia, 002+1001445568, hatattalla@hotmail.com
About this study
Official title: Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce Post-intubation Sore Throat in Shoulder Arthroscopic Surgeries: A Comparative Study
postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted.
Read the detailed description
postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted.In this study, 100 patients were intubated to undergo general anaesthesia for shoulder arthroscopy and randomised into one of two groups. An endotracheal tube was soaked in 8mg of dexamethasone for the first group intubation, while 10% lidocaine was sprayed over the tube for the second group. Following extubation, the two groups examined the severity of sore throats
- Conditions
- Postoperative Sore Throat
- Being tested
- Topical dexamethasone, 10% lidocaine was sprayed over the tube for the second group
- Keywords
- Sore-throat postoperative, dexamesthsone, 10% lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical dexamethasoneDrug
Patients were interviewed at 1 and 6 h after extubating for post-operative sore throat (POST). POST was assessed by a modified 4-point scale (0= no sore throat, 1= mild sore throat: complains of sore throat only on asking, 2 = moderate sore throat: complains of sore throat spontaneously, and 3 = severe sore throat: change of voice or hoarseness.
10% lidocaine was sprayed over the tube for the second groupDrug
Patients were interviewed at 1 and 6 h after extubating for post-operative sore throat (POST). POST was assessed by a modified 4-point scale (0= no sore throat, 1= mild sore throat: complains of sore throat only on asking, 2 = moderate sore throat: complains of sore throat spontaneously, and 3 = severe sore throat: change of voice or hoarseness.
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone group | Active comparator | An endotracheal tube was soaked in 8mg of dexamethasone for group I intubation Receives: Drug: Topical dexamethasone |
| lidocaine group | Active comparator | 10% lidocaine was sprayed over the tube Receives: Drug: 10% lidocaine was sprayed over the tube for the second group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Topical dexamethasone versus topical lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study
This study aimed to compare the effectiveness of topical applications of dexamethasone versus lidocaine spray in prevention sore throat.Patients will be assessed at 1 and 6 h after extubation for post-operative sore throat (POST). POST will be assessed by a modified 4-point scale (0= no sore throat, 1= mild sore throat: complains of sore throat only on asking, 2 = moderate sore throat: complains of sore throat spontaneously, and 3 = severe sore throat: change of voice or hoarseness.
Measured: 3MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mona elsaid, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266481
- Sponsor's protocol ID
- pua04202312313157
- Acronym
- post
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JH, Kim SB, Lee W, Ki S, Kim MH, Cho K, Lim SH, Lee KM, Choi DN, Oh M. Effects of topical dexamethasone in postoperative sore throat. Korean J Anesthesiol. 2017 Feb;70(1):58-63. doi: 10.4097/kjae.2017.70.1.58. Epub 2016 Nov 25.
PubMed 28184268Banihashem N, Alijanpour E, Hasannasab B, Zarei A. Prophylactic Effects of Lidocaine or Beclomethasone Spray on Post-Operative Sore Throat and Cough after Orotracheal Intubation. Iran J Otorhinolaryngol. 2015 May;27(80):179-84.
PubMed 26082898Jabbar ML, Mahboba JH, Meazher N. Comparing the effectiveness of topical dexamethasone emollient, lidocaine gel, and glycerin emollient on the endotracheal tube for postoperative hoarseness of voice, sore throat, and laryngospasm. J Med Life. 2023 Jun;16(6):904-907. doi: 10.25122/jml-2022-0137.
PubMed 37675167
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce Post-intubation Sore Throat in Shoulder Arthroscopic Surgeries: A Comparative Study
- ClinicalTrials.gov ID
- NCT06266481
- Acronym / sponsor ID
- post / pua04202312313157
- Conditions
- Postoperative Sore Throat
- Keywords
- Sore-throat postoperative, dexamesthsone, 10% lidocaine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 20 Feb 2024 (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 is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted.
Detailed description
postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted.In this study, 100 patients were intubated to undergo general anaesthesia for shoulder arthroscopy and randomised into one of two groups. An endotracheal tube was soaked in 8mg of dexamethasone for the first group intubation, while 10% lidocaine was sprayed over the tube for the second group. Following extubation, the two groups examined the severity of sore throats
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone group | Active comparator | Drug: Topical dexamethasoneAn endotracheal tube was soaked in 8mg of dexamethasone for group I intubation |
| lidocaine group | Active comparator | Drug: 10% lidocaine was sprayed over the tube for the second group10% lidocaine was sprayed over the tube |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- •Patients belonging to ASA physical status I, II
Key exclusion criteria (11 listed)
- Patients who are not willing to give consent for participation in the study
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 |
|---|---|---|
| Topical dexamethasonePatients were interviewed at 1 and 6 h after extubating for post-operative sore throat (POST). POST was assessed by a modified 4-point scale (0= no sore throat, 1= mild sore throat: complains of sore throat only on asking, 2 = moderate sore throat: complains of sore throat spontaneously, and 3 = severe sore throat: change of voice or hoarseness. | Drug | dexamethasone group |
| 10% lidocaine was sprayed over the tube for the second groupPatients were interviewed at 1 and 6 h after extubating for post-operative sore throat (POST). POST was assessed by a modified 4-point scale (0= no sore throat, 1= mild sore throat: complains of sore throat only on asking, 2 = moderate sore throat: complains of sore throat spontaneously, and 3 = severe sore throat: change of voice or hoarseness. | Drug | lidocaine group |
Primary outcome
Topical dexamethasone versus topical lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study
Time frame: 3MONTH
This study aimed to compare the effectiveness of topical applications of dexamethasone versus lidocaine spray in prevention sore throat.Patients will be assessed at 1 and 6 h after extubation for post-operative sore throat (POST). POST will be assessed by a modified 4-point scale (0= no sore throat, 1= mild sore throat: complains of sore throat only on asking, 2 = moderate sore throat: complains of sore throat spontaneously, and 3 = severe sore throat: change of voice or hoarseness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 28184268Lee JH, Kim SB, Lee W, Ki S, Kim MH, Cho K, Lim SH, Lee KM, Choi DN, Oh M. Effects of topical dexamethasone in postoperative sore throat. Korean J Anesthesiol. 2017 Feb;70(1):58-63. doi: 10.4097/kjae.2017.70.1.58. Epub 2016 Nov 25.
- Results publication: PubMed 26082898Banihashem N, Alijanpour E, Hasannasab B, Zarei A. Prophylactic Effects of Lidocaine or Beclomethasone Spray on Post-Operative Sore Throat and Cough after Orotracheal Intubation. Iran J Otorhinolaryngol. 2015 May;27(80):179-84.
- Results publication: PubMed 37675167Jabbar ML, Mahboba JH, Meazher N. Comparing the effectiveness of topical dexamethasone emollient, lidocaine gel, and glycerin emollient on the endotracheal tube for postoperative hoarseness of voice, sore throat, and laryngospasm. J Med Life. 2023 Jun;16(6):904-907. doi: 10.25122/jml-2022-0137.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Topical dexamethasone and 10% lidocaine was sprayed over the tube for the second group in people with Postoperative Sore Throat, run by Pharos University in Alexandria 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 5 inclusion and 11 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 20 Feb 2024. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 MONA el. Mssoud, ph anesthesia (002+01005542232, mona.elsaid@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Topical dexamethasone versus topical lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study (time frame: 3MONTH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266481, which also lists 3 linked publications.
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 20 Feb 2024.