Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-03-11 @ 9:09 PM
Study NCT ID:
NCT02327156
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2014-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-03-30', 'releaseDate': '2016-03-01'}, {'resetDate': '2019-06-06', 'releaseDate': '2019-03-06'}], 'estimatedResultsFirstSubmitDate': '2016-03-01'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2014-12-29', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the motor and sensory block durations', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 24 hours', 'description': 'expected to be extended in group LD'}], 'secondaryOutcomes': [{'measure': 'sleep quality of the 1st postoperative night', 'timeFrame': '24 hours', 'description': 'improved the sleep quality'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexmedetomidine'], 'conditions': ["Vitreoretinal Surgery Under Sub-Tenon's Anesthesia"]}, 'descriptionModule': {'briefSummary': "The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.", 'detailedDescription': "Background: The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.\n\nMethods: The investigator investigated 60 patients subjected to vitreoretinal surgery under sub-Tenon's anesthesia. The patients were randomly divided equally into 1 of 2 groups conferring to the local anesthesia (LA) solution used to receive either 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline (group L) or 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline (group LD). The total volume of the LA solution used was 5 mL. Motor block (akinesia) and sensory block durations were evaluated until the return of normal motor and sensory function. The sedation level was assessed during the surgery period and 24 hours postoperatively together with the degree of postoperative pain and the efficiency of postoperative analgesia. The sleep quality of the first postoperative night was assessed using the Consensus Sleep Diary (CSD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'inclusion criteria:\n\n* satisfactory akinesia\n* predictable surgical time to be less than 3 hours were inclusion criteria for this study\n\nExclusion Criteria:\n\n* incorporated patients younger than 18 years,\n* patients with a single eye,\n* history of sleep apnea,\n* severe cardiac disease, and\n* drug abuse or\n* if there was any contraindication to LA.'}, 'identificationModule': {'nctId': 'NCT02327156', 'acronym': 'Precedex', 'briefTitle': "Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia", 'organization': {'class': 'OTHER', 'fullName': 'Magrabi Eye & Ear Hospital'}, 'officialTitle': "The Effect of a Low-dose Dexmedetomidine as an Adjuvant to Levobupivacaine in Patients Undergoing Vitreoretinal Surgery Under Sub-Tenon's Anesthesia", 'orgStudyIdInfo': {'id': 'MEEC-IRB-2014-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'group L', 'description': 'receive 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group LD', 'description': '4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline', 'interventionNames': ['Drug: dexmedetomidine']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex, 200 μg per 2 mL; Hospira, USA'], 'description': 'adding dexmedetomidine to the local anesthetic', 'armGroupLabels': ['group LD']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magrabi Eye & Ear Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'SENIOR CONSULTANT', 'investigatorFullName': 'Ashraf M Ghali', 'investigatorAffiliation': 'Magrabi Eye & Ear Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-03-01', 'type': 'RELEASE'}, {'date': '2016-03-30', 'type': 'RESET'}, {'date': '2019-03-06', 'type': 'RELEASE'}, {'date': '2019-06-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ashraf M Ghali, SENIOR CONSULTANT, Magrabi Eye & Ear Hospital'}}}}