Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-21 @ 8:30 AM
Study NCT ID:
NCT03063866
Status:
UNKNOWN
Last Update Posted:
2017-04-27
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomised Controlled Study of Popofol Versus Midazolam as Sedation in Endoscopy With Advanced Liver Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2017-02-23', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of sedation', 'timeFrame': '6 months', 'description': 'Level of sedation using Ramsay sedation agitation score at before induction of sedation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases']}, 'referencesModule': {'references': [{'pmid': '29312786', 'type': 'DERIVED', 'citation': 'Ahmed SA, Selim A, Hawash N, Tawfik AK, Yousef M, Kobtan A, Badawi R, Elnawasany S, Elkhouly RA, Hanafy AS, Rizk FH, Mansour L, Abd-Elsalam S. Randomized Controlled Study Comparing Use of Propofol Plus Fentanyl versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients with Advanced Liver Disease. Int J Hepatol. 2017;2017:8462756. doi: 10.1155/2017/8462756. Epub 2017 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'Gastrointestinal endoscopy is a frequent procedure in the patients with advanced liver disease. It requires variable degree of sedation ranging from minimal sedation to general anesthesia aiming for relieving pain, anxiety, and bad memories of the procedure.\n\nIn conscious sedation, patients are able to make purposeful responses to auditory and tactile clues, with maintenance of ventilatory and circulatory stability. while, in deep sedation, patients respond only to painful stimuli, and airway support is frequently required. At the level of general anesthesia, patients are unresponsive, and airway support is mandatory.', 'detailedDescription': 'The aim of this study is to compare use of propofol or midazolam as sedative for patients with advanced liver disease presented for gastrointestinal endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 40 and 60 years old.\n* With Child score B or C\n* Presented for elective gastrointestinal endoscopy\n\nExclusion Criteria:\n\n* Emergent condition like hematemesis.\n* Patients with moderate to severe hepatic encephalopathy.\n* Patients with hepatopulmonary syndrome.\n* Patients with known or suspected hypersensitivity to the used medication were also excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03063866', 'briefTitle': 'Randomised Controlled Study of Popofol Versus Midazolam as Sedation in Endoscopy With Advanced Liver Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Randomised Controlled Study Comparing Use of Popofol Plus Fentanyl Versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients With Advanced Liver Disease.', 'orgStudyIdInfo': {'id': 'Sameh 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'M group', 'description': 'Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg', 'interventionNames': ['Drug: Midazolam', 'Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'P Group', 'description': 'Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v', 'interventionNames': ['Drug: Propofol', 'Drug: Fentanyl']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['propoven'], 'description': 'Propofol 1 mg/kg i.v', 'armGroupLabels': ['P Group']}, {'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Dormicum'], 'description': 'Midazolam 3 mg i.v', 'armGroupLabels': ['M group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Fantanyl'], 'description': 'fentanyl 0.5 ug/kg', 'armGroupLabels': ['M group', 'P Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-Elsalam, MD', 'role': 'CONTACT', 'email': 'sherif_tropical@yahoo.com', 'phone': '00201095159522'}], 'facility': 'Sherief Abd-Elsalam', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, MD', 'role': 'CONTACT', 'email': 'Sheriefabdelsalam@yahoo.com', 'phone': '00201095159522'}], 'overallOfficials': [{'name': 'Sameh Abdelkhalek Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University Faculty of Medicine'}, {'name': 'Sherief Abd-Elsalam, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanta university Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}