Postoperative Sore Throat, Cough, HoarsenessNCT07760272
Effect Of Intracuff Dexamethasone On Postoperative Sore Throat In Patients Undergoing Laparoscopic Cholecystectomy
A study testing Dexamethasone (0.1 mg/kg) and Normal Saline (0.9% NaCl) in people with Postoperative Sore Throat, Cough, Hoarseness, run by B.P. Koirala Institute of Health Sciences.
Trial summary
Postoperative sore throat is the most common complication following general anesthsia with endotracheal intubation with incidence ranging from 21 to 65% Although usually self-limiting, it significantly affects patient's comfort, satisfaction and may adversely affect the quality of recovery in postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Sore Throat, Cough, Hoarseness
- What is being tested?
- Dexamethasone (0.1 mg/kg) and Normal Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jun 2027
- Phase
- Interventional
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient aged 18-65 years.
- Either sex
- ASA physical status I or II
- Mallampatti grade I and II.
- Patient scheduled for elective laparoscopic cholecystectomy
- Patient requiring general anesthesia with endotracheal intubation
- Expected duration of surgery <2 hours.
- Patients /patient's family member who provide written informed consent.
Who cannot join
- Refusal for consent
- Mallampati grade III or IV
- More than two attempts at endotracheal intubation.
- Reintubation
- Use of bougie or stylet for intubation.
- Evidence of traumatic intubation (blood stained secretions or blood on ETT cuff)
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- Preexisting sore throat, hoarseness of voice or upper respiratory tract infection.
- Patient receiving systemic or inhaled steroids.
- Known case of allergy to dexamethasone.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: EFFECT OF INTRACUFF DEXAETHASONE ON POSTOPERATIVE SORE THROAT IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY
Postoperative sore throat is the most common complication following general anesthsia with endotracheal intubation with incidence ranging from 21 to 65% Although usually self-limiting, it significantly affects patient's comfort, satisfaction and may adversely affect the quality of recovery in postoperative period.
Laparoscopic cholecystectomy is one of the most performed laparoscopic surgeries and is routinely carried out under general anesthesia with endotracheal intubation. Several factors associated with this procedure like mechanical manipulation of airway during laryngoscopy and intubation, prolonged pressure of endotracheal tube cuff on the tracheal mucosa, pneumoperitoneum and positional changes during surgery may increase the risk of postoperative airway irritation and inflammation leading to sore throat, cough, hoarseness of voice.
Read more
various methods have been used for prevention of postoperative sore throat including topic local anesthetics, lubricants and systemic corticosteroid. Among sytemic steroid, Dexameathsone has shown to reduce airway inflammation and postoperative airway complications. However systemic administration may be associated with adverse effects such as hyperglycaemia, immunosupression and delayed wound healing.
Intracuff administration of dexamethasone provides an alternative approach that may help reduce postoperative airway complications while minimising systemic exposure. In this approach drug is instilled into the endotracheal tube cuff, causing it to gradually diffuse across the cuff membrane exerts local anti- inflammatory effect on the tracheal mucosa, thereby reducing inflammation and irritation exerts local anti- inflammatory effect on the tracheal mucosa, thereby reducing inflammation and irritation.
This study aims to evaluate the effect of intracuff dexamethasone on the incidence and severity of postoperative sore throat in patients undergoing laparoscopic cholecystectomy. The primary objective is to compare the incidence of postoperative sore throat between patients receiving intracuff dexamethasone and those receiving intracuff normal saline. Secondary objective includes comparing the severity of postoperative sore throat as well as the incidence and severity of postoperative cough and hoarseness of voice assessed within first 24 hours of surgery.
The study will be conducted as a prospective, double blind randomised controlled trial in the routine operation theatre of BP Koirala Institute of Health Sciences(BPKIHS),Dharan, Nepal. A total of 40 adult patients aged 18-65 years with ASA PS I or II and scheduled for elective laparoscopic cholecystectomy will be included. Participants will be randomly allocated in two groups in a ratio of 1:1. In the intervention group, cuff will be inflated with dexamethasone(0.01mg/g) diluted with normal saline, while in control group the cuff will be inflated with normal saline alone.
Postoperative sore throat, cough and hoarseness of voice will be assess at 2,6, 12 and 24 hours after extubation using standardised grading scale. Data will be analysed using SPSS software and MS Excel.
Continuous variables will be compared using the independent t test while the categorical variables will be analysed using the chi-square test or Fisher's test. A P value of<0.05 will be considered statistically significant.
Ethical approval will be obtained from the IRC of BPKIHS and NHRC. This study may help identify a simple and cost effective strategy to reduce postoperative airway discomfort and improve patient recovery after laparoscopic cholecytectomy.
- Being tested
- Dexamethasone (0.1 mg/kg), Normal Saline (0.9% NaCl)
- Medical subject headings
- Cough, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (0.1 mg/kg)Drug
Dexamethasone 0.1 mg/kg diluted with normal saline to the required cuff volume will be used to inflate the cuff of the endotracheal tube immediately after tracheal intubation. The intervention will be administered once during induction of general anesthesia.
Normal Saline (0.9% NaCl)Drug
Normal saline will be used to inflate the cuff of the endotracheal tube to the required cuff volume immediately after tracheal intubation. The intervention will be administered once during induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intracuff Dexamethasone | Experimental | Participants receive dexamethasone 0.1 mg/kg diluted with normal saline to inflate the cuff of the endotracheal tube immediately after tracheal intubation. General anesthesia and perioperative management are standardized according to the study protocol. Receives: Drug: Dexamethasone (0.1 mg/kg); Drug: Normal Saline (0.9% NaCl) |
| Intracuff normal saline | Placebo comparator | Participants receive normal saline to inflate the cuff of the endotracheal tube immediately after tracheal intubation. General anesthesia and perioperative management are otherwise identical to those of the experimental group. Receives: Drug: Dexamethasone (0.1 mg/kg); Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative sore throat (POST)
Measured: Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)
Secondary outcomes (3)
Severity of postoperative sore throat
Measured: Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)
Incidence of postoperative cough
Measured: Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)
Incidence of postoperative hoarseness of voice
Measured: Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore Throat, Cough, HoarsenessStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group receives intracuff dexamethasone, while the control group receives intracuff normal saline. Each participant receives only one study intervention.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MONIKA KC, B.P. Koirala Institute of Health Sciences
- Investigators
- Monika KC, Principal investigator, B.P. Koirala Institute of Health Sciences, Dharan, NepalKrishna Pokharel, Study chair, B.P. Koirala Institute of Health Sciences, Dharan, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760272
- Sponsor's protocol ID
- 214-2026
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because there is no planned data-sharing arrangement for this study. The collected data will be used only for the purposes of this research, while maintaining participant confidentiality and complying with institutional ethical requirements.