Trimebutine Maleate for Enhancing Gastric Visualization in Acute Upper Gastrointestinal Bleeding
Role of Trimebutine Maleate in Enhancing Endoscopic Gastric Visualization in Patients With Acute Upper Gastrointestinal Bleeding: A Double-Blind Randomized Controlled Trial
Acute upper gastrointestinal bleeding is a medical emergency that requires an urgent upper endoscopy to locate and treat the source of the bleeding. Often, retained blood and clots in the stomach make it difficult for the endoscopist to clearly see the stomach's anatomical structures.
This study aims to evaluate if administering a medication called Trimebutine Maleate before the endoscopy can help empty the stomach of residual blood and improve the doctor's view. Trimebutine Maleate is a widely prescribed medication that regulates gastrointestinal movement and has a favorable safety profile compared to other medications used for this purpose.
Researchers will include 100 adult patients experiencing acute upper gastrointestinal bleeding who are scheduled for an urgent endoscopy within 24 hours of presentation. Participants will be randomly assigned to receive either 50 mg of intravenous Trimebutine Maleate or a matching placebo (saline solution) 60 to 90 minutes before their procedure. All participants will continue to receive standard medical treatment for their bleeding according to normal hospital protocols.
The primary goal of the study is to compare the clarity of the stomach view between the two groups using a standardized Gastric Visualization Score. The research team will also measure how often the exact bleeding source is successfully identified, the total duration of the procedure, and whether patients require a repeat endoscopy or a stomach washout (gastric lavage).
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age ≥18 years.
- Clinical evidence of AUGIB: Hematemesis, coffee-ground vomiting or melena.
- Planned urgent upper gastrointestinal endoscopy within 24 hours.
Exclusion Criteria:
- Known gastric outlet obstruction.
- Previous gastric surgery.
- Pregnancy or lactation.
- Allergy to Trimebutine Maleate.
- Chronic use of prokinetic medications.
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：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Trimebutine Maleate Group
Participants in this group will receive an intravenous administration of 50 mg Trimebutine Maleate approximately 60 to 90 minutes prior to their scheduled urgent upper gastrointestinal endoscopy.
All patients will also receive standard medical treatment for acute upper gastrointestinal bleeding according to institutional protocols.
|
50 mg of Trimebutine Maleate administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.
|
|
プラセボコンパレーター：Placebo Group
Participants in this group will receive a matching placebo, consisting of an ampoule of saline, administered approximately 60 to 90 minutes prior to their scheduled urgent upper gastrointestinal endoscopy.
All patients will also receive standard medical treatment for acute upper gastrointestinal bleeding according to institutional protocols.
|
A matching placebo consisting of an ampoule of saline administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.
|
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 |
|---|---|---|
|
Total Gastric Visualization Score
時間枠：60 to 90 minutes post-intervention
|
Gastric visualization will be assessed by the endoscopist across five anatomical areas: the fundus, upper body, lower body, antrum, and duodenum.
Each area is evaluated using a 4-point scale: 0 (large amount of blood/clots obscuring vision), 1 (moderate blood requiring suction), 2 (small amount of blood with adequate visualization), and 3 (excellent visualization).
The scores from all five areas are summed to create a Total Gastric Visualization Score ranging from 0 to 15, with higher scores indicating better visualization.
|
60 to 90 minutes post-intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Identification Rate of Bleeding Source
時間枠：60 to 90 minutes post-intervention
|
Percentage of participants in whom the specific anatomical source of upper gastrointestinal bleeding is successfully identified during the endoscopy procedure.
|
60 to 90 minutes post-intervention
|
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
- Trimebutine for UGIB Endoscopy
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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