Airway EdemaPhase 4NCT07918495
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
A Phase 4 study testing Dexamethasone in people with Airway Edema and Postoperative Complications, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Airway Edema, Postoperative Complications, Cholecystolithiasis
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 4
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 40 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
Who cannot join
- Patient refusal to participate
- Known renal or hepatic disease
- History of difficult tracheal intubation
- Known obstructive sleep apnea (OSA)
- Severe cardiopulmonary disease
- Pregnancy
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- Known hypersensitivity or contraindication to dexamethasone
- Chronic or recent systemic corticosteroid therapy
- Intraoperative conversion from laparoscopic to open cholecystectomy
About this study
Official title: 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.
Read more
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.
- Being tested
- Dexamethasone, Normal Saline Placebo
- Keywords
- Dexamethasone, Airway Ultrasonography, Laparoscopic Cholecystectomy, Pneumoperitoneum, Lateral Pharyngeal Wall, Tongue Thickness, General Anesthesia
- Medical subject headings
- Postoperative Complications, Cholecystolithiasis, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
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.
Normal Saline PlaceboOther
Also called 0.9% Sodium Chloride
A single intravenous injection of 10 mL of 0.9% normal saline, administered prior to the induction of general anesthesia in an identical syringe.
| Study group | Role | What they receive |
|---|---|---|
| Group D: Dexamethasone Group | Experimental | 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. Receives: Drug: Dexamethasone |
| Group C: Placebo Control Group | Placebo comparator | Participants receive a single intravenous volume of 10 mL of 0.9% normal saline administered prior to the induction of general anesthesia. Receives: Other: Normal Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to immediately before extubation (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway EdemaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Essam Galal Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918495
- Sponsor's protocol ID
- Dexamethasone on Airway in LC
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy: Randomized Double Blinded Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT07918495
- Acronym / sponsor ID
- Dexamethasone on Airway in LC
- Keywords
- Dexamethasone, Airway Ultrasonography, Laparoscopic Cholecystectomy, Pneumoperitoneum, Lateral Pharyngeal Wall, Tongue Thickness, General Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Nov 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D: Dexamethasone Group | Experimental | Drug: DexamethasoneParticipants 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. |
| Group C: Placebo Control Group | Placebo comparator | Other: Normal Saline PlaceboParticipants receive a single intravenous volume of 10 mL of 0.9% normal saline administered prior to the induction of general anesthesia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 40 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
Key exclusion criteria (9 listed)
- Patient refusal to participate
- Known renal or hepatic disease
- History of difficult tracheal intubation
- Known obstructive sleep apnea (OSA)
- Severe cardiopulmonary disease
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 |
|---|---|---|
| DexamethasoneA 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. | Drug | Group D: Dexamethasone Group |
| Normal Saline PlaceboAlso: 0.9% Sodium ChlorideA single intravenous injection of 10 mL of 0.9% normal saline, administered prior to the induction of general anesthesia in an identical syringe. | Other | Group C: Placebo Control Group |
Primary outcome
Change from Baseline in Total Bilateral Lateral Pharyngeal Wall (LPW) Thickness at Pre-extubation
Time frame: From baseline to immediately before extubation (T2)
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).
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 5 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Airway Edema and Postoperative Complications, run by Assiut University.
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 9 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Total Bilateral Lateral Pharyngeal Wall (LPW) Thickness at Pre-extubation (time frame: From baseline to immediately before extubation (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.