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Prophylaxis for Aspiration of Gastric Contents.

NCT02703896 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1920

Last updated 2016-03-09

No results posted yet for this study

Summary

Effect of orally administered two equal and consecutive doses of proton pump inhibitors, omeprazole, lansoprazole, esomeprazole , rabeprazole and pantoprazole and Histamine 2 receptor antagonists cimetidine, ranitidine,famotidine,nizatidine and lafutidine without and with a prokinetic agents domperidone, metoclopramide and erythromycin on intragastric pH, volume and bile refluxate.

Conditions

  • Pulmonary Aspiration of Gastric Contents

Interventions

DRUG

Drug either PPIS or H2RA and prokinetics

Drug intervention ( dose unit mg) Two oral doses 8:00 p.m. and 6:00 a.m. (n=60) total 10 groups 1. Group C (placebo),Group L (lansoprazole15 ), Group LD (Lansoprazole 15 +domperidone 10 ) 2. Group C ,R (rabeprazole 10), RM (rabeprazole 10 + metoclopramide 10) 3. Group C , E (esomeprazole 20 ), and EM (esomeprazole 20 + metoclopramide 10) 4. Group C, P (pantoprazole 20), and PD (pantoprazole 20 + domperidone 10 mg) 5. Group C, O (omeprazole 20), OD (omeprazole 20 + domepridone 10), OM (omeprazole 20 + metoclopramide 10) 6. Group C,T (cimetidine 200), TD (cimetidine 200 + domperidone 10) 7. Group C , Z (ranitidine 150), ZD (ranitidine 150 + domperidone 10) 8. Group C , N (nizatidine 150),NM (nizatidine 150 + metoclopramide 10) 9. Group C, F (famotidine 20 mg), and FM (famotidine 20 mg + metoclopramide 10) 10. Group C,S (lafutidine 10), SD (lafutidine 10 + domperidone 10), and Group SM (lafutidine 10 + metoclopramide 10)

PROCEDURE

orogastric intubation

OGT insertion:Insertion of orogastric tube(through an endotracheal tube placed in the upper esophagus) into the stomach after general anaesthesia.

Sponsors & Collaborators

  • King Saud University

    lead OTHER

Principal Investigators

  • ALTAF HUSSAIN, FCPS,EDAIC · Assistant Professor and Consultant Anaesthetist

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-01-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02703896 on ClinicalTrials.gov