Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-01-01 @ 6:48 PM
Study NCT ID:
NCT05342818
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2022-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D050338', 'term': 'Phenylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2022-04-17', 'studyFirstSubmitQcDate': '2022-04-17', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Gastric Residual Volume(GRV)', 'timeFrame': '12 hours', 'description': "Patients' GRVs will be evaluated before the intervention, then 3, 6, 9 and 12 hours after the intervention using a gavage syringe by an expert nurse who had been unaware of the study groups"}, {'measure': 'Volume of the gastric antrum', 'timeFrame': '4 days', 'description': 'After five half-lives of drugs, the volume of the gastric antrum of the patients will be measured by ultrasonography 3 hours after gavage.'}], 'secondaryOutcomes': [{'measure': 'Blood albumin', 'timeFrame': '4 days', 'description': 'blood sampling daily for four days'}, {'measure': 'Complete Blood Count', 'timeFrame': '4 days', 'description': 'blood sampling daily for four days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric residual volume', 'neostigmine', 'ondansetron', 'mechanically ventilated patients'], 'conditions': ['Delayed Gastric Emptying']}, 'descriptionModule': {'briefSummary': "One big problem in mechanically ventilated ICU patients is delayed gastric emptying. Delayed gastric emptying in these patients, causes intolerance and high gastric residual volume (GRV) that can lead to abdominal distention, vomiting, increased aspiration risk and consequently increased the length of hospital stay.\n\nIn this study, investigators will evaluate Neostigmine's effect in reducing GRV in mechanically ventilated patients and compare its effect with metoclopramide and Ondansetron\n\n.", 'detailedDescription': 'It has been shown that delayed gastric emptying and high GRV in critically ill patients are associated with increased mortality in these patients. Different kinds of drugs including metoclopramide, erythromycin and cisapride are used, but none of them had conclusive evidence of better effects on each other. Moreover, complications such as dysrhythmia and extrapyramidal side effects limit the use of these drugs.\n\nAnother drug that can be used to increase gastric emptying in critically ill patients is neostigmine. Although several studies have evaluated the efficacy of neostigmine on postoperative ileus, very few studies have evaluated the effect of this drug on GRV in ICU patients.\n\nThe aim of the current study will be to compare the effects of Neostigmine on gastric residual volume in mechanically ventilated patients in the intensive care unit. A comparative controlled study by Ondansetron.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanically ventilated ICU patients\n* With nasogastric tube feeding\n* Gastric Residual Volume \\>120 mL (3hours after the last gavage)\n\nExclusion Criteria:\n\n* History of diabetes\n* Heart block\n* Bradycardia (heart rate \\<60/min)\n* Systolic blood pressure less than 90 mm Hg\n* Renal insufficiency\n* Using any prokinetic agents such as erythromycin or cisapride within 8 hours before study initiation\n* Recent surgery (10 days or less) on the stomach or digestive system\n* pregnancy and lactation\n* Occurrence of extrapyramidal side effects\n* Gastrointestinal (GI) bleeding'}, 'identificationModule': {'nctId': 'NCT05342818', 'briefTitle': 'Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Neostigmine Effect on Gastric Residual Volume on Mechanically Ventilated Patients in the Intensive Care Unit. A Comparative Controlled Study by Ondansetron', 'orgStudyIdInfo': {'id': 'IRC112/04/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group N', 'description': 'patients will receive an intravenous infusion of neostigmine in a dose of 2.5 mg in 100 ml of normal saline within 20 minutes once daily', 'interventionNames': ['Drug: Neostigmine', 'Other: Enteral feeding nutrition', 'Other: Sequential Organ Failure Assessment (SOFA) score']}, {'type': 'EXPERIMENTAL', 'label': 'Group O', 'description': 'patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes', 'interventionNames': ['Drug: Ondansetron 8mg', 'Other: Enteral feeding nutrition', 'Other: Sequential Organ Failure Assessment (SOFA) score']}, {'type': 'EXPERIMENTAL', 'label': 'Group M', 'description': 'patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion', 'interventionNames': ['Drug: Metoclopramide Injection', 'Other: Enteral feeding nutrition', 'Other: Sequential Organ Failure Assessment (SOFA) score']}], 'interventions': [{'name': 'Neostigmine', 'type': 'DRUG', 'otherNames': ['Neostigmine injection'], 'description': 'will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs', 'armGroupLabels': ['Group N']}, {'name': 'Ondansetron 8mg', 'type': 'DRUG', 'otherNames': ['Dansetron injection'], 'description': 'will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs', 'armGroupLabels': ['Group O']}, {'name': 'Metoclopramide Injection', 'type': 'DRUG', 'otherNames': ['primperan injection'], 'description': 'will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs', 'armGroupLabels': ['Group M']}, {'name': 'Enteral feeding nutrition', 'type': 'OTHER', 'otherNames': ['Enteral feeding'], 'description': 'The type and rate of enteral feeding nutrition will be the same for all patients (180ml/3h). All patients have a 30-degree head-up position', 'armGroupLabels': ['Group M', 'Group N', 'Group O']}, {'name': 'Sequential Organ Failure Assessment (SOFA) score', 'type': 'OTHER', 'otherNames': ['SOFA score'], 'description': 'SOFA score will be performed on all patients before the beginning of the study', 'armGroupLabels': ['Group M', 'Group N', 'Group O']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000000', 'city': 'Sharurah', 'country': 'Saudi Arabia', 'facility': 'Sharurah Armed Forces Hospital', 'geoPoint': {'lat': 17.49083, 'lon': 47.11262}}], 'overallOfficials': [{'name': 'AHMED A SHAMA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'LECTURER OF ANESTHESIA AND SURGICAL ICU', 'investigatorFullName': 'AHMED ABDELAZIZ SHAMA', 'investigatorAffiliation': 'Tanta University'}}}}