Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Multicenter, Double-blind Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All adult patients (aged ≥ 18years)

• Active UGIB who arrived at emergency room (ER) and had a schedule for EGD within 12 hours after onset of bleeding ; Active UGIB was defined as having hematemesis or fresh blood by diagnostic gastric lavage at the ER.

Locations
Other Locations
Thailand
King Chulalongkorn memorial hospital
RECRUITING
Bangkok
King Chulalongkorn Memorial hospital
NOT_YET_RECRUITING
Bangkok
Contact Information
Primary
Thanrada Vimonsuntirungsri, MD
aa_choc@docchula.com
+66853356240
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 220
Treatments
Experimental: Metoclopramide group
Metoclopramide 10 mg +NSS 10ml IV 30-60 min before EGD
Placebo_comparator: Placebo group
NSS 10 ml IV 30-60 min before EGD
Related Therapeutic Areas
Sponsors
Leads: King Chulalongkorn Memorial Hospital

This content was sourced from clinicaltrials.gov