Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-01-15 @ 12:14 PM
Study NCT ID:
NCT02863861
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
2016-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2016-08-08', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of stay in PACU', 'timeFrame': 'three months'}]}, 'conditionsModule': {'keywords': ['Sedation', 'Pediatric Patients'], 'conditions': ['Upper Gastrointestinal Endoscopy']}, 'referencesModule': {'references': [{'pmid': '33293038', 'type': 'DERIVED', 'citation': 'Amer AM, Youssef AM, El-Ozairy HS, El-Hennawy AM. [Propofol-ketamine versus dexmedetomidine-ketamine for sedation during upper gastrointestinal endoscopy in pediatric patients: a randomized clinical trial]. Braz J Anesthesiol. 2020 Nov-Dec;70(6):620-626. doi: 10.1016/j.bjan.2020.08.005. Epub 2020 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compere between Propofol-Ketamine combination and Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in paediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists ASA I-II patients aging 2-7 years.\n\nExclusion Criteria:\n\nknown allergy to any of the study drugs, significant cardiovascular disease vomiting.'}, 'identificationModule': {'nctId': 'NCT02863861', 'briefTitle': 'Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparative Study Between Propofol-Ketamine Combination and Dexmedetomidine-Ketamine Combination for Sedation in Upper Gastrointestinal Endoscopy in Paediatric Patients.', 'orgStudyIdInfo': {'id': 'FMASU R 12/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group PK', 'description': 'Propofol-Ketamine group: patients in this group will receive IV ketamine at a dose of 1mg.kg-1 in addition to IV propofol 1mg.kg-1 for induction with added doses of propofol 1mg.kg-1 when needed.', 'interventionNames': ['Drug: propofol-ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Group DK', 'description': 'Dexmedetomidine-Ketamine group: patients in this group will receive IV ketamine at a dose of 1mg.kg-1 in addition to IV dexmedetomidine 0.5 mcg.kg-1 for induction with additional doses of dexmedetomidine 0.5mcg.kg-1 when required', 'interventionNames': ['Drug: Dexmedetomidine-ketamine']}], 'interventions': [{'name': 'Dexmedetomidine-ketamine', 'type': 'DRUG', 'armGroupLabels': ['Group DK']}, {'name': 'propofol-ketamine', 'type': 'DRUG', 'armGroupLabels': ['Group PK']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams university- faculty of medicine- department of anesthesia, intensive care and pain management', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Department of Anesthesiology, Intensive Care, and Pain Management, Faculty of Medicine, Ain-Shams University', 'investigatorFullName': 'Akram Mohamed Mohamed Amer', 'investigatorAffiliation': 'Ain Shams University'}}}}