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This study aim to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB. This is a double-blinded, multicenter RCT. Patients with 'active' UGIB (hematemesis or presence of fresh blood in the nasogastric tube) were enrolled. The eligible patients were randomly assigned in a concealed 1:1 allocation to received either intravenous metoclopramide or placebo before endoscopy. The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). Secondary outcomes included mean difference in total EVS and EVS at each location , duration of EGD, immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramide group | Experimental | Metoclopramide 10 mg +NSS 10ml IV 30-60 min before EGD |
|
| Placebo group | Placebo Comparator | NSS 10 ml IV 30-60 min before EGD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide Sulfone | Drug | Metoclopramide 10mg+NSS 10 ml IV 30-60 minutes before EGD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with 'adequate visualization' | 'adequate visualization' is determined by objective scoring method (endoscopic visualized scores (EVS) to estimate the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb; At each location was assessed and scored between 0 and 2: 0, blood clot cover more than 75% of the surface ; 1, 25-75% blood clot coverage ; 2, blood clot coverage less than 25%. ; score >=6 considered as adequate visualization | Through study completion, estimate 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The mean difference in EVS | total of four locations and at each location including fundus, corpus, antrum and duodenal bulb | Through study completion, estimate 2 years |
| Duration of esophagogastroduodenoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thanrada Vimonsuntirungsri, MD | Contact | +66853356240 | aa_choc@docchula.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn memorial hospital | Recruiting | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C075797 | metoclopramide sulfone |
| D000077330 | Saline Solution |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline 10 mL Injection | Drug | Normal saline 10 ml IV 30-60 minutes before EGD |
|
| 10minutes to 2 hours |
| Immediate hemostasis | Rate of succession of hemostasis (bleeding stop) at first EGD | Through study completion, estimate 2 years |
| The need for a second look EGD within 72 hours after initial endoscopy | Rate of need for a second look EGD within 72 hours after initial endoscopy The 72-hour recurrent GI bleeding was documented and re-EGD was performed to confirm rebleeding if the following conditions were met: I) hematemesis or bloody nasogastric tube (NG) > 6 hours after endoscopy; II) melena after normalization of stool color; III) hematochezia after normalization of stool color or melena; IV) development of tachycardia (HR ≥ 110 bpm) or hypotension(SBP ≤ 90 mmHg) after ≥ 1 hour of vital sign stability without other cause; V) hemoglobin drop of ≥ 2 g/dL after two consecutive stable hemoglobin values ( < 0.5 g/dL decrease) ≥ 3 hours apart; VI) tachycardia or hypotension that does not resolve within 8 hours after index endoscopy despite appropriate resuscitation (in the absence of an alternative explanation), associated with persistent melena or hematochezia or; VII) persistently dropping hemoglobin of > 3 g/dL in 24 hours associated with persistent melena or hematochezia. | Up to 72 hours |
| Number of unit of red blood cell transfusion during first 24 hours | Number of of unit of red blood cell transfusions during first 24 hours | Up to 24 hours |
| Length of hospital stays | Length of hospital stays of participants | 1day - 30days |
| 30-day rebleeding rate | rate of 30-day rebleeding of upper GI tract | Up to 30 days |
| King Chulalongkorn Memorial hospital | Not yet recruiting | Bangkok | 10330 | Thailand |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004333 |
| Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |