Effect Of Intracuff Dexamethasone On Postoperative Sore Throat In Patients Undergoing Laparoscopic Cholecystectomy

NCT07760272 | Not Yet Recruiting DMC

• 1 other identifier: 214-2026
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Postoperative Sore Throat, Cough, Hoarseness

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative sore throat (POST)

  Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)

Secondary Outcomes (3)

• Severity of postoperative sore throat

  Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)

• Incidence of postoperative cough

  Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)

• Incidence of postoperative hoarseness of voice

  Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)

Study Arms (2)

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.

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.

Drug: Dexamethasone (0.1 mg/kg); Drug: Normal Saline (0.9% NaCl)

Interventions

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.

Intracuff Dexamethasone; Intracuff normal saline

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.

Intracuff Dexamethasone; Intracuff normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Preexisting sore throat, hoarseness of voice or upper respiratory tract infection.
• Patient receiving systemic or inhaled steroids.
• Known case of allergy to dexamethasone.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

MeSH Terms

Conditions

Cough; Hoarseness

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Monika KC

  B.P. Koirala Institute of Health Sciences, Dharan, Nepal

  PRINCIPAL INVESTIGATOR

• Krishna Pokharel

  B.P. Koirala Institute of Health Sciences, Dharan, Nepal

  STUDY CHAIR

Central Study Contacts

Monika KC, P

CONTACT

+977 -9765021194; monikakc52@gmail.com

Krishna Pokharel

CONTACT

+977-9802330604; drkrishnapokharel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study solution is prepared by an independent anesthesiologist who is not involved in patient management or outcome assessment. Participants, anesthesia providers, investigators, and postoperative outcome assessors remain blinded to treatment allocation until completion of data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior resident

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share