drugset / Trial / NCT04771481

Metoclopramide for Acute Upper GI Bleeding

NCT04771481 ↗

Phase 4 Completed 68 enrolled King Chulalongkorn Memorial Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

The presence of blood clot in stomach limited quality of endoscopic view ,which affect successful rate of hemostatic endoscopy in patient with acute upper gastrointestinal bleeding. The study is aimed to evaluate the efficacy of metoclopramide, as pro-kinetic agent ,for gastric visualization in the patient with acute UGIB; double-blind randomized controlled trial and two centers study. The patient were randomly assigned to receive either metoclopramide (10mg) intravenously or placebo before endoscopy 30-120 min. The primary endpoint was endoscopic yield, assessed by objective gastric visualized scoring systems. Secondary end points include duration of endoscope, technical success rate, the need for second-look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.

Timeline

Start
2021-04-10
Primary completion
2022-09-07
Completion
2022-10-08

Outcome

Missed primary endpoint

paper The percentage of patients with adequate visualization in metoclopramide and placebo group was 77.4% and 61.6% (odds ratio [OR] 2.16 [0.71-6.58], P = 0.16). PMID 38059896 ↗

paper Metoclopramide did not improve endoscopic visualization but decreased the need for second look EGD in patients with overall active UGIB. PMID 38059896 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Metoclopramide Small molecule 10 mg Intravenous

Indications

No indication recorded.