Post Operative Sore Throat at 6hrs and 24hrs After Endotracheal IntubationPhase 1/2NCT07256834
Comparison of Efficacy of Betamethasone Gel With Lidocaine Gel in Prevention of Post Endotracheal Intubation Sore Throat.
A Phase 1/2 study testing Betamethasone dipropionate 0.05% and Lidocaine hydrochloride 2% in people with Post Operative Sore Throat at 6hrs and 24hrs After Endotracheal Intubation, run by Jinnah Postgraduate Medical Centre.
Trial summary
The goal of this clinical trial is to compare the incidence of postoperative sore throat in adult patients of either gender belonging to ASA I or II ,undergoing endotracheal intubation using betamethasone gel versus lidocaine gel. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Sore Throat at 6hrs and 24hrs After Endotracheal Intubation
- What is being tested?
- Betamethasone dipropionate 0.05% and Lidocaine hydrochloride 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 22 Nov 2025to 6 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-60 years
- Either gender
- ASA I to II
- Patients planned for elective surgery under general anesthesia not lasting more than 4 hours.
Who cannot join
- Patients requiring more than 2 attempts for successful intubation
- Patients undergoing surgeries of oral cavity or pharynx
- Mallampati Score of 3 or 4
- Patients with upper respiratory tract infection
- Patients already taking steroids
- Use of nasogastric tube perioperatively
About this study
Official title: Incidence of Sore Throat in Postoperative Patients After Use of Betamethasone Gel Compared With Lidocaine Gel During Endotracheal Intubation
The goal of this clinical trial is to compare the incidence of postoperative sore throat in adult patients of either gender belonging to ASA I or II ,undergoing endotracheal intubation using betamethasone gel versus lidocaine gel. It aims to determine
1: Difference in efficacy of Betamethasone gel and lidocaine gel in prevention of post operative sore throat after endotracheal intubation.
Patients will be assessed for the presence of a sore throat at 6 hours and 24 hours postoperatively. The severity of the sore throat will be graded using the Post-Operative Sore Throat (POST) score.
Read the detailed description
This study aims to resolve the debate over the superiority of betamethasone versus lidocaine in preventing POST. Achieving clarity on this issue will not only reduce patient morbidity but also help decrease the duration of hospital stays and lower hospital bed occupancy.The study will commence following the approval of the synopsis by the Research Department of the College of Physicians and Surgeons, Pakistan (CPSP). All patients scheduled for elective surgery under general anesthesia who fulfil the inclusion criteria will be included in the study from Jinnah Postgraduate Medical Center (JPMC). Informed written consent will be obtained from the patients prior to their inclusion in the study.
Initial data, including name, date of presentation, age, weight, height, BMI and gender will be recorded on a predesigned proforma. Patients will then be divided into two group (A and B) through simple random sampling software. In Group A patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 0.05% Betamethasone dipropionate gel, from distal end of cuff to 15cm mark on endotracheal tube. In Group B patients, lubrication will be done in a similar manner using 2.5ml of 2% Lidocaine gel. After induction of anesthesia (with IV Propofol 2.5mg/kg, Nalbuphine 0.1mg/kg, Atracurium 0.5mg/kg) and 3 minutes of bag mask ventilation, trachea will be intubated with endotracheal tube of size 7 or 7.5mm according to internal diameter of trachea. Successful endotracheal intubation will be confirmed by capnography and bilaterally equal air entry. Maintenance of general anesthesia will be done by Isoflurane and 60% oxygen mixed with compressed air. Upon completion of surgery, Isoflurane will be discontinued, and residual neuromuscular blockage will be antagonized by Neostigmine 0.05mg/kg. The trachea will be extubated after the patient is fully awake. All patients will be shifted to post-anesthesia care unit where standard ASA monitoring will be continued by a team of anesthetists. The presence and grading of Postoperative sore throat will be done by researcher himself, according to POST Scores at 6 and 24 hours postoperatively, in presence of consultant anesthetist of 5 years of experience. The study will be relevant and specific towards its objective and proper exclusion criteria will be used to control any bias / confounders.
- Being tested
- Betamethasone dipropionate 0.05%, Lidocaine hydrochloride 2%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone dipropionate 0.05%Drug
It is corticosteroid indicated for relief of inflammatory and pruritic manifestation
Lidocaine hydrochloride 2%Drug
It is amide local anesthetic used for lubrication and pain prevention as topical anesthetic regimen
| Study group | Role | What they receive |
|---|---|---|
| Group A receiving betamethasone gel during endotracheal intubation | Active comparator | Group A patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 0.05% Betamethasone dipropionate gel, from distal end of cuff to 15cm mark on endotracheal tube Receives: Drug: Betamethasone dipropionate 0.05% |
| Group B receiving lidocaine gel during endotracheal intubation | Active comparator | Group B patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 2% Lidocaine gel, from distal end of cuff to 15cm mark on endotracheal tube Receives: Drug: Lidocaine hydrochloride 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative sore throat
Comparing presence and grading of sore throat in both arms after endotracheal intubation.
Measured: Sore throat after endotracheal intubation at 6 hrs and 24hrs post operatively. Sample completion in 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start22 Nov 2025 (estimated)
- Primary completion6 Dec 2025 (estimated)
- Study completion6 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Sore Throat at 6hrs and 24hrs After Endotracheal IntubationStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256834
- Sponsor's protocol ID
- F.2-81/2025-GENL/429/JPMC
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Sore Throat in Postoperative Patients After Use of Betamethasone Gel Compared With Lidocaine Gel During Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT07256834
- Acronym / sponsor ID
- F.2-81/2025-GENL/429/JPMC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 22 Nov 2025 (estimated)
- Primary completion
- 6 Dec 2025 (estimated)
- Study completion
- 6 Dec 2025 (estimated)
- First posted
- 1 Dec 2025 (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.
The goal of this clinical trial is to compare the incidence of postoperative sore throat in adult patients of either gender belonging to ASA I or II ,undergoing endotracheal intubation using betamethasone gel versus lidocaine gel. It aims to determine
1: Difference in efficacy of Betamethasone gel and lidocaine gel in prevention of post operative sore throat after endotracheal intubation.
Patients will be assessed for the presence of a sore throat at 6 hours and 24 hours postoperatively. The severity of the sore throat will be graded using the Post-Operative Sore Throat (POST) score.
Detailed description
This study aims to resolve the debate over the superiority of betamethasone versus lidocaine in preventing POST. Achieving clarity on this issue will not only reduce patient morbidity but also help decrease the duration of hospital stays and lower hospital bed occupancy.The study will commence following the approval of the synopsis by the Research Department of the College of Physicians and Surgeons, Pakistan (CPSP). All patients scheduled for elective surgery under general anesthesia who fulfil the inclusion criteria will be included in the study from Jinnah Postgraduate Medical Center (JPMC). Informed written consent will be obtained from the patients prior to their inclusion in the study.
Initial data, including name, date of presentation, age, weight, height, BMI and gender will be recorded on a predesigned proforma. Patients will then be divided into two group (A and B) through simple random sampling software. In Group A patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 0.05% Betamethasone dipropionate gel, from distal end of cuff to 15cm mark on endotracheal tube. In Group B patients, lubrication will be done in a similar manner using 2.5ml of 2% Lidocaine gel. After induction of anesthesia (with IV Propofol 2.5mg/kg, Nalbuphine 0.1mg/kg, Atracurium 0.5mg/kg) and 3 minutes of bag mask ventilation, trachea will be intubated with endotracheal tube of size 7 or 7.5mm according to internal diameter of trachea. Successful endotracheal intubation will be confirmed by capnography and bilaterally equal air entry. Maintenance of general anesthesia will be done by Isoflurane and 60% oxygen mixed with compressed air. Upon completion of surgery, Isoflurane will be discontinued, and residual neuromuscular blockage will be antagonized by Neostigmine 0.05mg/kg. The trachea will be extubated after the patient is fully awake. All patients will be shifted to post-anesthesia care unit where standard ASA monitoring will be continued by a team of anesthetists. The presence and grading of Postoperative sore throat will be done by researcher himself, according to POST Scores at 6 and 24 hours postoperatively, in presence of consultant anesthetist of 5 years of experience. The study will be relevant and specific towards its objective and proper exclusion criteria will be used to control any bias / confounders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A receiving betamethasone gel during endotracheal intubation | Active comparator | Drug: Betamethasone dipropionate 0.05%Group A patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 0.05% Betamethasone dipropionate gel, from distal end of cuff to 15cm mark on endotracheal tube |
| Group B receiving lidocaine gel during endotracheal intubation | Active comparator | Drug: Lidocaine hydrochloride 2%Group B patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 2% Lidocaine gel, from distal end of cuff to 15cm mark on endotracheal tube |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18-60 years
- Either gender
- ASA I to II
- Patients planned for elective surgery under general anesthesia not lasting more than 4 hours.
Key exclusion criteria (6 listed)
- Patients requiring more than 2 attempts for successful intubation
- Patients undergoing surgeries of oral cavity or pharynx
- Mallampati Score of 3 or 4
- Patients with upper respiratory tract infection
- Patients already taking steroids
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 |
|---|---|---|
| Betamethasone dipropionate 0.05%It is corticosteroid indicated for relief of inflammatory and pruritic manifestation | Drug | Group A receiving betamethasone gel during endotracheal intubation |
| Lidocaine hydrochloride 2%It is amide local anesthetic used for lubrication and pain prevention as topical anesthetic regimen | Drug | Group B receiving lidocaine gel during endotracheal intubation |
Primary outcome
Post operative sore throat
Time frame: Sore throat after endotracheal intubation at 6 hrs and 24hrs post operatively. Sample completion in 2 weeks
Comparing presence and grading of sore throat in both arms after endotracheal intubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Betamethasone dipropionate 0.05% and Lidocaine hydrochloride 2% in people with Post Operative Sore Throat at 6hrs and 24hrs After Endotracheal Intubation, run by Jinnah Postgraduate Medical Centre.
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 4 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: opening soon, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative sore throat (time frame: Sore throat after endotracheal intubation at 6 hrs and 24hrs post operatively. Sample completion in 2 weeks). 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 1 Dec 2025.