Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-01 @ 11:52 PM
Study NCT ID:
NCT05215158
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2022-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D058647', 'term': 'Adrenergic alpha-2 Receptor Agonists'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000316', 'term': 'Adrenergic alpha-Agonists'}, {'id': 'D000322', 'term': 'Adrenergic Agonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2022-01-18', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of analgesia', 'timeFrame': '12 hours', 'description': 'The time gap between the abolition of the sensation using gauze soaked in cooled normal saline, or corneal reflex, and the first postoperative demand for analgesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Squint']}, 'referencesModule': {'references': [{'pmid': '39621979', 'type': 'DERIVED', 'citation': 'Ghazaly HF, Hassan IE, Gabr AF, Dardeer TT, Alazhary MA. Intravenous Versus Peribulbar Dexmedetomidine as an Adjunct to Local Anesthetics in Strabismus Surgery: A Randomized, Double-blinded Clinical Trial. Pain Physician. 2024 Nov;27(8):E819-E827.'}]}, 'descriptionModule': {'briefSummary': 'Using various adjuvants has become a trend in regional anesthesia practice to improve the quality of anesthesia and prolong postoperative analgesia. Dexmedetomidine, an alpha-2 agonist has been proposed as a safe and effective adjunct capable of extending the duration of the single-shot block', 'detailedDescription': 'Strabismus (misalignment of the eye) results from a difference in extraocular muscle function. Consequently, two different images, one from each eye, are transmitted to the brain, resulting in a loss of visual depth. In adults, cosmetic appearance is the main issue but sudden occurrence of strabismus may cause diplopia because the brain cannot suppress the overlapping images. The goal of strabismus surgery is to align the eyes, reduce diplopia, and restore binocular vision Ophthalmic regional block can be used as the primary anesthetic technique for strabismus surgery. The advantages of ophthalmic regional blockade include a reduced incidence of oculocardiac reflex (OCR) and emergence agitation, postoperative analgesia, and decreased postoperative nausea and vomiting (PONV).\n\nUsing various adjuvants has become a trend in regional anesthesia practice to improve the quality of anesthesia and prolong postoperative analgesia. Dexmedetomidine, an alpha-2 agonist has been proposed as a safe and effective adjunct capable of extending the duration of the single-shot block.\n\nPerineural dexmedetomidine, when added to bupivacaine, has been shown to potentiate its effects, providing a better quality of anesthesia and postoperative analgesia. Intravenous (I.V.) dexmedetomidine, when used during regional anesthesia, has been shown to prolong sensory and motor blockade in addition to sedation and postoperative analgesia.\n\nNo previous studies where different routes of dexmedetomidine have been compared in adult strabismus surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient planned to perform a unilateral strabismus surgery\n2. Age: 20-60 years\n3. American Society of Anesthesiologists class I and II\n\nExclusion Criteria:\n\n1. patients under the age of 20\n2. uncooperative patients\n3. Patients with coagulopathy\n4. patients who disincline to participate in the study will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT05215158', 'briefTitle': 'Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'A Comparative Study of Intravenous Versus Peribulbar Administration of Dexmedetomidine for Strabismus Surgery in Adults', 'orgStudyIdInfo': {'id': '520/3/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Peribulbar dexmedetomidine', 'description': 'The peribulbar block will be done using a mixture of 4 ml Lidocaine 2%, 4 ml Bupivacaine 0.5%, and 2 ml normal saline containing 50 μg dexmedetomidine perineurally (30 patients).', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous dexmedetomidine', 'description': 'The peribulbar block will be done using a mixture of 4 ml Lidocaine 2%, 4 ml Bupivacaine 0.5%, and 2 ml normal saline. Patients received 50 μg dexmedetomidine in 50 mL of normal saline administered as an infusion over 10 minutes, and given 10 minutes before the peribulbar block (30 patients).', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['alpha-2 agonist'], 'description': 'to compare perineural (peribulbar) dexmedetomidine versus intravenous (I.V.) dexmedetomidine when used as an adjuvant with local anesthesia in adult strabismus surgery.', 'armGroupLabels': ['Intravenous dexmedetomidine', 'Peribulbar dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81511', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}, {'zip': '81511', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Huda Fahmy', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Anesthesia and Intensive Care', 'investigatorFullName': 'Huda Fahmy Mahmoud, PhD', 'investigatorAffiliation': 'Aswan University Hospital'}}}}