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Trial record 88 of 185 for:    ERYTHROMYCIN

Prophylaxis for Aspiration of Gastric Contents.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02703896
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
ALTAF HUSSAIN, King Saud University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Aspiration of Gastric Contents Drug: Drug either PPIS or H2RA and prokinetics Procedure: orogastric intubation Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1920 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: "Effect of Orally Administered Two Successive Doses of PPIs and/ or H2RAs Without or With a Prokinetic Drug, on the Intragastric pH and Volume and Bile Refluxate in Adults Patients Undergoing Elective Surgery.
Study Start Date : January 2012
Actual Primary Completion Date : January 2012
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Placebo Comparator: Group C (placebo)

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

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)
Other Names:
  • Drug treatment
  • lansoprazole, esomeprazole,pantoprazole,rebeprazole, omeprazole,cimetidine,nizatidine,famotidine,ranitidine,lafutidine

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

Active Comparator: Either PPIs or H2RAs

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

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)
Other Names:
  • Drug treatment
  • lansoprazole, esomeprazole,pantoprazole,rebeprazole, omeprazole,cimetidine,nizatidine,famotidine,ranitidine,lafutidine

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

Active Comparator: Either PPIs or H2RAs+prokinetics

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

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)
Other Names:
  • Drug treatment
  • lansoprazole, esomeprazole,pantoprazole,rebeprazole, omeprazole,cimetidine,nizatidine,famotidine,ranitidine,lafutidine

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

Active Comparator: Either PPIs or H2RAs+Prokinetic
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

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)
Other Names:
  • Drug treatment
  • lansoprazole, esomeprazole,pantoprazole,rebeprazole, omeprazole,cimetidine,nizatidine,famotidine,ranitidine,lafutidine

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

Intervention Orogastric intubation
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

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)
Other Names:
  • Drug treatment
  • lansoprazole, esomeprazole,pantoprazole,rebeprazole, omeprazole,cimetidine,nizatidine,famotidine,ranitidine,lafutidine

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




Primary Outcome Measures :
  1. pH of gastric contents [ Time Frame: Immediate after induction of general anaesthesia ]
    pH was measured with pH meter. Unit whole digit with two decimal point for example, 4.24


Secondary Outcome Measures :
  1. volume of gastric contents [ Time Frame: Immediate after induction of general anesthesia. ]
    Measured with graduated syringe. Units milliliters (ml)


Other Outcome Measures:
  1. bile salts in the gastric contents [ Time Frame: immediate after induction of general anesthesia. ]
    Hay's Sulfur test performed on gastric contents, reported as positive or negative for bile salts



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: ASA I and II aged 15-70 years

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Exclusion Criteria:

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

.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703896


Sponsors and Collaborators
King Saud University
Investigators
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Principal Investigator: ALTAF HUSSAIN, FCPS,EDAIC Assistant Professor and Consultant Anaesthetist

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Responsible Party: ALTAF HUSSAIN, Assistant professor, King Saud University
ClinicalTrials.gov Identifier: NCT02703896    
Other Study ID Numbers: 06-546
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by ALTAF HUSSAIN, King Saud University:
g a, bile reflux. PPIs, H2RAs, prokinetic agents
Additional relevant MeSH terms:
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Respiratory Aspiration of Gastric Contents
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
Metoclopramide
Domperidone
Omeprazole
Esomeprazole
Rabeprazole
Pantoprazole
Lansoprazole
Dexlansoprazole
Famotidine
Ranitidine
Ranitidine bismuth citrate
Cimetidine
Nizatidine
Lafutidine
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors