Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-04 @ 8:34 AM
Study NCT ID:
NCT02495220
Status:
UNKNOWN
Last Update Posted:
2017-01-27
First Post:
2015-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2015-07-03', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics', 'timeFrame': '4 hours postoperatively', 'description': 'by analysis for number of infants withCRIES pain scale score \\>3'}, {'measure': 'postoperative CRIES pain scale score', 'timeFrame': '4 hours postoperatively', 'description': '(0-2 for each parameter)'}], 'secondaryOutcomes': [{'measure': 'vomiting scale score', 'timeFrame': '4 hours postoperative', 'description': 'a numeric rank score, where 0= no vomiting 1=vomited once and 2=vomited twice or more'}, {'measure': 'Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%).', 'timeFrame': 'intraoperative period', 'description': 'by analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'subtenon anesthesia', 'postoperative pain', 'pov'], 'conditions': ['Postoperative Pain', 'Postoperative Vomiting']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.', 'detailedDescription': 'In this prospective, randomized, controlled, double blind trial eighty ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia were studied. Infants were randomly allocated to one of the two groups: subtenon block Group (SB) with dexmedetomidine (n =40) or intravenous dexmedetomidine Group (IV) (n =40). After securing the airway, infants in Group (SB) received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture, whereas infants in Group (IV) received 1µ/kg IV dexmedetomidine after induction of anesthesia. Surgery started after 5 min of study drug administration. Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics was the primary outcome. CRIES pain scale score , vomiting scale score during4-h study period, incidence of oculocardiac reflex and any surgical difficulty were the Secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA physical status grade I and II infants (1-12month).\n2. undergoing elective cataract surgery in one eye under general anesthesia.\n\nExclusion Criteria:\n\n1. infection of the orbit,\n2. increased intraocular pressure(IOP),\n3. history of allergy to local anesthetics,\n4. history of previous eye surgery,\n5. cardiovascular or clotting disorders,\n6. full stomach,inner ear disorders or other conditions predisposing to vomiting\n7. airway abnormalities\n8. compromised sclera.'}, 'identificationModule': {'nctId': 'NCT02495220', 'briefTitle': 'Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Subtenon Versus Intravenous Dexmedetomidine for Postoperative Analgesia and Vomiting Control in Infantile Cataract Surgery', 'orgStudyIdInfo': {'id': 'IRB00008711068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'subtenon block Group (SB)', 'description': 'received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture', 'interventionNames': ['Drug: SB dexmedetomidine bupivacaine block']}, {'type': 'EXPERIMENTAL', 'label': 'intravenous dexmedetomidine Group(IV)', 'description': 'received 1µ/kg IV dexmedetomidine after induction of anesthesia', 'interventionNames': ['Drug: intravenous dexmedetomidine']}], 'interventions': [{'name': 'SB dexmedetomidine bupivacaine block', 'type': 'DRUG', 'description': 'SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture', 'armGroupLabels': ['subtenon block Group (SB)']}, {'name': 'intravenous dexmedetomidine', 'type': 'DRUG', 'description': 'received 1µ/kg IV dexmedetomidine', 'armGroupLabels': ['intravenous dexmedetomidine Group(IV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'jehan A Sayed, MD', 'role': 'CONTACT', 'email': 'jehan.alloul@yahoo.com', 'phone': '+2 01006253939'}, {'name': 'MD', 'role': 'CONTACT'}, {'name': 'Mohamed Amir F Riad, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'jehan A Sayed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assiut Univeristy Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'jehan A sayed, MD', 'role': 'CONTACT', 'email': 'jehan.alloul@yahoo.com', 'phone': '+2 01006253939'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor in anesthesia and intensive care department,faculty of medicine assiut university', 'investigatorFullName': 'jehan ahmed sayed', 'investigatorAffiliation': 'Assiut University'}}}}