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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
プラセボコンパレーター：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Total Bilateral Lateral Pharyngeal Wall (LPW) Thickness at Pre-extubation
時間枠：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)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Dexamethasone on Airway in LC
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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