Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy

Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy: Randomized Double Blinded Placebo Controlled Study

During laparoscopic surgery, the abdomen is inflated with carbon dioxide gas (pneumoperitoneum), which alters venous return and fluid distribution, potentially leading to swelling in the tissues of the upper airway. The placement of a breathing tube (endotracheal tube) under general anesthesia can also cause local airway irritation and edema. Although these airway dimension changes are frequently clinically silent, they can be accurately visualized and quantified at the bedside using non-invasive ultrasonography.

Dexamethasone is a corticosteroid with potent anti-inflammatory and anti-edematous actions commonly administered before surgery to alleviate postoperative nausea, vomiting, and sore throat. However, whether it helps prevent or attenuate measurable increases in airway wall thickness during and after laparoscopic surgery remains unclear.

The primary purpose of this randomized clinical trial is to evaluate whether a single preventive intravenous dose of dexamethasone attenuates upper-airway swelling, measured primarily by lateral pharyngeal wall thickness via ultrasound, in adult patients undergoing elective laparoscopic cholecystectomy.

Participants are randomly allocated into one of two groups:

• Dexamethasone Group: Receives an intravenous dose of dexamethasone (0.2 mg/kg) diluted in 10 mL normal saline prior to the induction of general anesthesia.
• Placebo Group: Receives an identical volume of 10 mL normal saline intravenously prior to the induction of general anesthesia.

Bedside ultrasound scans will be performed by a blinded assessor to evaluate lateral pharyngeal wall thickness, tongue thickness, and parapharyngeal space dimensions at five specific time points: before anesthesia induction, 30 minutes following pneumoperitoneum initiation, immediately prior to extubation, 1 hour after extubation, and 2 hours after extubation. Participants are also evaluated for any post-extubation airway complications or symptoms during their stay in the recovery unit.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications; Cholecystolithiasis; Airway Edema
• Intervention / Treatment: Drug: Dexamethasone; Other: Normal Saline Placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 to 40 years
• American Society of Anesthesiologists (ASA) physical status I or II
• Scheduled for elective laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

• Patient refusal to participate
• Known renal or hepatic disease
• History of difficult tracheal intubation
• Known obstructive sleep apnea (OSA)
• Severe cardiopulmonary disease
• Pregnancy
• Known hypersensitivity or contraindication to dexamethasone
• Chronic or recent systemic corticosteroid therapy
• Intraoperative conversion from laparoscopic to open cholecystectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group D: Dexamethasone Group; Participants receive a single intravenous dose of dexamethasone 0.2 mg/kg diluted in 10 mL of 0.9% normal saline administered prior to the induction of general anesthesia.	Drug: Dexamethasone; A single intravenous dose of dexamethasone 0.2 mg/kg diluted into 10 mL of 0.9% normal saline, administered prior to the induction of general anesthesia.
Placebo Comparator: Group C: Placebo Control Group; Participants receive a single intravenous volume of 10 mL of 0.9% normal saline administered prior to the induction of general anesthesia.	Other: Normal Saline Placebo; A single intravenous injection of 10 mL of 0.9% normal saline, administered prior to the induction of general anesthesia in an identical syringe.; Other Names: 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Total Bilateral Lateral Pharyngeal Wall (LPW) Thickness at Pre-extubation	Assessed via bedside ultrasonography using a high-frequency linear transducer (7-15 MHz) with the patient in the supine position. Lateral pharyngeal wall (LPW) thickness is defined as the shortest perpendicular distance (in millimeters) between the medial border of the internal carotid artery (ICA) and the echogenic pharyngeal mucosal surface measured at end-expiration. On each side, three separate measurements are obtained after probe removal and repositioning, and the mean is calculated. The total bilateral LPW thickness is calculated as the sum of the right and left mean thicknesses (in mm). The change is calculated by subtracting baseline values (T0) from values obtained immediately before extubation (T2).	From baseline to immediately before extubation (T2)

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 31, 2026
• First Submitted That Met QC Criteria: October 31, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: October 31, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Pneumoperitoneum; Dexamethasone; Laparoscopic Cholecystectomy; General Anesthesia; Airway Ultrasonography; Tongue Thickness; Lateral Pharyngeal Wall
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Biliary Tract Diseases; Peritoneal Diseases; Gallbladder Diseases; Cholelithiasis; Pathological Conditions, Signs and Symptoms; Pneumoperitoneum; Postoperative Complications; Cholecystolithiasis; Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexamethasone; Sodium Chloride
• Other Study ID Numbers: Dexamethasone on Airway in LC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No