Post Operative Sore ThroatPhase 2NCT07823192
A Randomized Controlled Trial Evaluating the Efficacy of Soaking Endotracheal Tube in Dexamethasone Solution for Prevention of Postoperative Sore Throat After Laparoscopic Cholecystectomy
A Phase 2 study testing Steroid Drug and Normal (0.9%) saline in people with Post Operative Sore Throat, run by KRL Hospital, Islamabad at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if topical application of dexamethasone will prevent sore throat caused by endotracheal intubation in healthy patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Sore Throat
- What is being tested?
- Steroid Drug and Normal (0.9%) saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2026to Mar 2027
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing general anesthesia requiring ETT insertion during elective laparoscopic cholecystectomy.
- ASA I \& ASA II patients
- Patients consenting to be a part of the study
Who cannot join
- Patients having diabetes mellitus
- Patients with suspected or incidental difficult Intubation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Topical Dexamethasone Tube Soaking for Prevention of Postoperative Sore Throat (POST) Following Endotracheal Intubation for Laparoscopic Cholecystectomy: A Randomized Controlled Trial
The goal of this clinical trial is to learn if topical application of dexamethasone will prevent sore throat caused by endotracheal intubation in healthy patients undergoing elective surgery. The main question it aims to answer is:
- Does soaking the endotracheal tube in steroid solution before intubation lower the incidence of postoperative sore throat? Researcher will compare dexamethasone-soaked endotracheal tube to placebo (normal saline-soaked endotracheal tube) to see if topical steroid application in this way reduces development of sore throat.
Read more
Participants will be:
- Intubated with an endotracheal tube, that was either soaked in normal saline or dexamethasone solution, at induction of general anesthesia prior to undergoing elective cholecystectomy
- Interviewed by the researcher 24 hours after their surgery to assess if they experienced any throat soreness
- Conditions
- Post Operative Sore Throat
- Being tested
- Steroid Drug, Normal (0.9%) saline
- Keywords
- post operative sore throat, ETT soaking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid DrugDrug
Endotracheal tube will be soaked in dexamethasone solution for 10 minutes prior to intubation
Normal (0.9%) salineDrug
Endotracheal tube will be soaked in normal saline for 10 minutes prior to intubation
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone group | Experimental | Participants intubated with endotracheal tube soaked in dexamethasone solution Receives: Drug: Steroid Drug |
| Normal saline group | Placebo comparator | Participants intubated with endotracheal tube soaked in normal saline Receives: Drug: Normal (0.9%) saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post operative sore throat
Proportion of patients who develop sore throat after surgery
Measured: Within 24 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KRL Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Niaz, KRL Hospital, Islamabad
- Investigators
- Dr Ammar Ali Shah, MBBS DA FCPS MHPE Fellowship, Study chair, KRL Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823192
- Sponsor's protocol ID
- KRL-HI-PUB-ERC/207
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be kept confidential and not shared publicly
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 28184268
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Dexamethasone Tube Soaking for Prevention of Postoperative Sore Throat (POST) Following Endotracheal Intubation for Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07823192
- Acronym / sponsor ID
- KRL-HI-PUB-ERC/207
- Conditions
- Post Operative Sore Throat
- Keywords
- post operative sore throat, ETT soaking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- KRL Hospital, IslamabadUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Sep 2026 (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 learn if topical application of dexamethasone will prevent sore throat caused by endotracheal intubation in healthy patients undergoing elective surgery. The main question it aims to answer is:
- Does soaking the endotracheal tube in steroid solution before intubation lower the incidence of postoperative sore throat? Researcher will compare dexamethasone-soaked endotracheal tube to placebo (normal saline-soaked endotracheal tube) to see if topical steroid application in this way reduces development of sore throat.
Participants will be:
- Intubated with an endotracheal tube, that was either soaked in normal saline or dexamethasone solution, at induction of general anesthesia prior to undergoing elective cholecystectomy
- Interviewed by the researcher 24 hours after their surgery to assess if they experienced any throat soreness
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Experimental | Drug: Steroid DrugParticipants intubated with endotracheal tube soaked in dexamethasone solution |
| Normal saline group | Placebo comparator | Drug: Normal (0.9%) salineParticipants intubated with endotracheal tube soaked in normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing general anesthesia requiring ETT insertion during elective laparoscopic cholecystectomy.
- ASA I \& ASA II patients
- Patients consenting to be a part of the study
Key exclusion criteria (2 listed)
- Patients having diabetes mellitus
- Patients with suspected or incidental difficult Intubation
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 |
|---|---|---|
| Steroid DrugEndotracheal tube will be soaked in dexamethasone solution for 10 minutes prior to intubation | Drug | Dexamethasone group |
| Normal (0.9%) salineEndotracheal tube will be soaked in normal saline for 10 minutes prior to intubation | Drug | Normal saline group |
Primary outcome
Incidence of post operative sore throat
Time frame: Within 24 hours of surgery
Proportion of patients who develop sore throat after surgery
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 16 Sep 2026.
- Background: 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.
- Individual participant dataSharing planned: No. Individual participant data will be kept confidential and not shared publicly
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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.
Dr Ammar Ali Shah, MBBS DA FCPS MHPE Fellowship study chair
KRL Hospital, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Steroid Drug and Normal (0.9%) saline in people with Post Operative Sore Throat, run by KRL Hospital, Islamabad at 1 site in Pakistan.
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 3 inclusion and 2 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 16 Sep 2026. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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 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?
Contact Mariam Niaz, MBBS (+923391715167, dr.mariamniaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post operative sore throat (time frame: Within 24 hours of surgery). 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 NCT07823192, which also lists 1 linked publication.
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 16 Sep 2026.