An interventional study of Dexamethasone (0.1 mg/kg) and Normal Saline (0.9% NaCl) in Postoperative Sore Throat, Cough, Hoarseness, sponsored by B.P. Koirala Institute of Health Sciences. Not yet recruiting. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by B.P. Koirala Institute of Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →B.P. Koirala Institute of Health Sciences is the lead sponsor of 54 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Refusal for consent
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dexamethasone (0.1 mg/kg) · Drug: Normal Saline (0.9% NaCl)
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.
Drug: Dexamethasone (0.1 mg/kg) · Drug: Normal Saline (0.9% NaCl)
Drug page: Dexamethasone
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 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.
Incidence of postoperative sore throat (POST)
Time frame: Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)
Severity of postoperative sore throat
Time frame: Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)
Incidence of postoperative cough
Time frame: Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)
Incidence of postoperative hoarseness of voice
Time frame: Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
B.P. Koirala Institute of Health Sciences