Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT04668456
Status:
UNKNOWN
Last Update Posted:
2021-02-25
First Post:
2020-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '75 Patients were assigned into three equal groups, all patients received 2.5 ml of local anesthetic mixture through subtenon block and IV infusion of drugs as follows: Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.\n\nGroup SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.\n\nGroup ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of sensory block', 'timeFrame': '24 hours', 'description': 'time from injection of local anesthetic mixture to complete recovery from pain sensation or the first need of rescue analgesia'}], 'secondaryOutcomes': [{'measure': 'duration of motor block', 'timeFrame': '24 hours', 'description': 'time from injection of local anesthetic to complete recovery of motor function in all ocular muscles.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subtenon', 'dexmedetomidine', 'cataract surgery'], 'conditions': ['Acute Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery.', 'detailedDescription': "Ophthalmological surgery can be performed under topical, regional or general anesthesia. Recently, the majority of ocular surgeries performed by regional rather than general anesthesia, because of the regional anesthesia is more economic, easy to perform, and the risk involved is less. Orbital regional anesthesia can be done using a retrobulbar (intra-conal) block, peribulbar (extra-conal) block or sub-Tenon's block.\n\nThe STBs or episcleral block was first described by Turnbull in 1884 and it was repopularized in the 1990s as a simple and safe alternative to needle-based eye blocks. The STB becomes the most widely practiced regional technique for cataract surgery, because it produces satisfactory anesthesia for most intraocular procedures, and avoids the inherent risks of needle-based blocks, such as globe perforation and optic nerve injury.\n\nDexmedetomidine is a selective α-2 receptor agonist that produces sedation and analgesia without causing respiratory depression. It also allows patients to respond to verbal commands during the sedation; easy conversion from sleeping to awakening is possible. Therefore, dexmedetomidine has been used as sedative in various clinical fields in intensive care unit and surgery and an adjuvant to local anesthetics.\n\nMany studies were done to evaluate its effect as sedative or anlgesic when administered either intravenously or when added to local anesthesia in ophthalmic block. But no one, till now comparing its effect when used as adjuvant to local anesthetics or administered intravenously in subtenon block."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA grade I-III\n* Aged 18-70 years\n* Both sex\n* Scheduled for elective phacoemulsification cataract surgery\n\nExclusion Criteria:\n\n* Coagulation abnormalities\n* Impaired mental status\n* Refusal of the patient\n* Uncontrolled glaucoma\n* Recent surgical procedure on the same eye'}, 'identificationModule': {'nctId': 'NCT04668456', 'briefTitle': 'Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'The Effect of Subtenon and Intravenous Dexmedetomidine on Patients Undergoing Cataract Surgery: A Comparative Randomized Controlled Double Blind Study', 'orgStudyIdInfo': {'id': '8/8/2020 ANET4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group C (control group)', 'description': 'Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.', 'interventionNames': ['Drug: lidocaine 2%', 'Drug: bupivacine 0.5%', 'Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group SD (subtenon dexmedetomiine)', 'description': 'Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: lidocaine 2%', 'Drug: bupivacine 0.5%', 'Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group ID (iv dexmedetomidine)', 'description': 'Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: lidocaine 2%', 'Drug: bupivacine 0.5%']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'the drug administered either subtenon ot iv', 'armGroupLabels': ['Group ID (iv dexmedetomidine)', 'Group SD (subtenon dexmedetomiine)']}, {'name': 'lidocaine 2%', 'type': 'DRUG', 'description': 'subtenon injection', 'armGroupLabels': ['Group C (control group)', 'Group ID (iv dexmedetomidine)', 'Group SD (subtenon dexmedetomiine)']}, {'name': 'bupivacine 0.5%', 'type': 'DRUG', 'description': 'subtenon injection', 'armGroupLabels': ['Group C (control group)', 'Group ID (iv dexmedetomidine)', 'Group SD (subtenon dexmedetomiine)']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'either subtenon or iv', 'armGroupLabels': ['Group C (control group)', 'Group SD (subtenon dexmedetomiine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1234', 'city': 'Shibīn al Kawm', 'state': 'Monufia Governorate', 'country': 'Egypt', 'facility': 'Ashraf magdy Eskandr', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}, {'zip': '1234', 'city': 'Shibīn al Kawm', 'state': 'Monufia Governorate', 'country': 'Egypt', 'facility': 'Osama A Elmorsy', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}, {'zip': '1234', 'city': 'Shibīn al Kawm', 'state': 'Monufia Governorate', 'country': 'Egypt', 'facility': 'Sadik A Sadik', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor of anesthesia, icu', 'investigatorFullName': 'ashraf magdy eskandr', 'investigatorAffiliation': 'Menoufia University'}}}}