Prophylaxis for Aspiration of Gastric Contents.

NCT02703896 | Completed Phase 4 DMC

• 1 other identifier: 06-546
• Study Type: interventional
• Target: 1,920
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

g a, bile reflux. PPIs, H2RAs, prokinetic agents

Outcome Measures

Primary Outcomes (1)

• pH of gastric contents

  pH was measured with pH meter. Unit whole digit with two decimal point for example, 4.24

  Immediate after induction of general anaesthesia

Secondary Outcomes (1)

• volume of gastric contents

  Immediate after induction of general anesthesia.

Other Outcomes (1)

• bile salts in the gastric contents

  immediate after induction of general anesthesia.

Study Arms (5)

Group C (placebo)

PLACEBO COMPARATOR

Drug intervention Two doses of Placebo at 8.00 pm and then at 6.00 am 1. Group C (placebo) 2. Group C (placebo) 3. Group C (placebo) 4. Group C (placebo) 5. Group C (placebo) 6. Group C (placebo) 7. Group C (placebo) 8. Group C (placebo) 9. Group C (placebo) 10. Group C (placebo)

Drug: Drug either PPIS or H2RA and prokinetics; Procedure: orogastric intubation

Either PPIs or H2RAs

ACTIVE COMPARATOR

Drug Intervention Two doses at 8.00 pm and then at 6.00 am 1. Group L (lansoprazole 15 mg) 2. Group E(esomeprazole 20 mg) 3. Group P (pantoprazole 20 mg) 4. Group R (rabeprazole 10 mg) 5. Group O (omeprazole 20 mg) 6. Group T (cimetidine 200 mg) 7. Group F (famotidine 20 mg) 8. Group N (nizatidine 150 mg) 9. Group Z (ranitidine 150 mg) 10. Group S (lafutidine 10 mg)

Drug: Drug either PPIS or H2RA and prokinetics; Procedure: orogastric intubation

Either PPIs or H2RAs+prokinetics

ACTIVE COMPARATOR

Drug intervention Two doses at 8.00 pm and then at 6.00 am 1. Group L D (lansoprazole 15 mg+ domperidone 10 mg) 2. Group EM (esomeprazole 20 mg+metoclopramide 10 mg) 3. Group PD (pantoprazole 20 mg+domperidone 10) 4. Group RM (rabeprazole 10 mg+metoclopramide 10 mg) 5. Group OD (omeprazole 20 mg+domperidone 10) 6. Group TD (cimetidine 200 mg+domperidone 10) 7. Group FM (famotidine 20 mg+metoclopramide 10 mg) 8. Group NM (nizatidine 150 mg+metoclopramide 10 mg) 9. Group ZD (ranitidine 150 mg+ domperidone 10 mg) 10. Group SD (lafutidine 10 mg+domperidone 10 mg)

Drug: Drug either PPIS or H2RA and prokinetics; Procedure: orogastric intubation

Either PPIs or H2RAs+Prokinetic

ACTIVE COMPARATOR

Drug intervention Two doses at 8.00 pm and then at 6.00 am Group OM (omeprazole 20 mg +metoclopramide 10 mg) Group SM (lafutidine 10 mg + metoclopramide 10 mg )

Drug: Drug either PPIS or H2RA and prokinetics; Procedure: orogastric intubation

Intervention Orogastric intubation

OTHER

After general anesthesia, an oro-gastric tube was inserted through another endotracheal tube placed in upper esophagus into the stomach for aspiration of gastric contents.

Drug: Drug either PPIS or H2RA and prokinetics; Procedure: orogastric intubation

Interventions

Drug either PPIS or H2RA and prokinetics DRUG

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)

Also known as: Drug treatment, lansoprazole, esomeprazole,pantoprazole,rebeprazole, omeprazole,cimetidine,nizatidine,famotidine,ranitidine,lafutidine

Either PPIs or H2RAs; Either PPIs or H2RAs+Prokinetic; Either PPIs or H2RAs+prokinetics; Group C (placebo); Intervention Orogastric intubation

orogastric intubation PROCEDURE

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

Also known as: OGT Insertion

Either PPIs or H2RAs; Either PPIs or H2RAs+Prokinetic; Either PPIs or H2RAs+prokinetics; Group C (placebo); Intervention Orogastric intubation

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with upper gastrointestinal disorders, Body mass index above 35 kg/m2, Receiving medicines known to effect the secretory and or motor functions of stomach, Had undergone surgery on stomach, With difficult intubation Intestinal obstruction, Partuients and Diabetes

Sponsors & Collaborators

• King Saud University: lead

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Interventions

Lansoprazole; Esomeprazole

Condition Hierarchy (Ancestors)

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole

Study Officials

• ALTAF HUSSAIN, FCPS,EDAIC

  Assistant Professor and Consultant Anaesthetist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: March 9, 2016
• Study Start: January 1, 2012
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2015
• Last Updated: March 9, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share