- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07918495
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Comparatore placebo: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Baseline in Total Bilateral Lateral Pharyngeal Wall (LPW) Thickness at Pre-extubation
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie dell'apparato digerente
- Malattie delle vie biliari
- Malattie peritoneali
- Malattie della cistifellea
- Colelitiasi
- Condizioni patologiche, segni e sintomi
- Pneumoperitoneo
- Complicanze postoperatorie
- Colecistolitiasi
- Composti policiclici
- Prodotti chimici inorganici
- Composti di cloro
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Steroidi, fluorurati
- Incintadienetrioli
- Composti di sodio
- Cloruri
- Acido cloridrico
- Desametasone
- Cloruro di sodio
Altri numeri di identificazione dello studio
- Dexamethasone on Airway in LC
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .