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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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
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-vergelijker: 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. |
A single intravenous injection of 10 mL of 0.9% normal saline, administered prior to the induction of general anesthesia in an identical syringe.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline in Total Bilateral Lateral Pharyngeal Wall (LPW) Thickness at Pre-extubation
Tijdsspanne: 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). |
From baseline to immediately before extubation (T2)
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Ziekten van het spijsverteringsstelsel
- Ziekten van de galwegen
- Peritoneale ziekten
- Galblaas Ziekten
- Cholelithiase
- Pathologische aandoeningen, tekenen en symptomen
- Pneumoperitoneum
- Postoperatieve complicaties
- Cholecystolithiase
- Polycyclische verbindingen
- Anorganische chemicaliën
- Chloorverbindingen
- Zwangerschap
- Zwangere
- Steroïden
- Verbindingen met gefuseerde ring
- Steroïden, gefluoreerd
- Zwangerschap
- Natriumverbindingen
- Chloriden
- Zoutzuur
- Dexamethason
- Natriumchloride
Andere studie-ID-nummers
- Dexamethasone on Airway in LC
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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