Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-29 @ 7:54 PM
Study NCT ID:
NCT04498351
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2020-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Prospective randomized double blinded clinical study on humans'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Following skin sterilization and local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle is inserted in-plane to the ultrasound beam in a cranial-to-caudal direction the spermatic cord in short axis and directed towards the deferent duct, contralateral to the testicular artery. The needle tip was advanced to become contact with the deferent. Correct location of the needle tip was confirmed by injecting 0.5-1 ml to see the local anesthetic spreading around the deferent duct. A total of 18ml levobupivacaine 0.5% are then injected into the spermatic cord block .\n\nThe procedure is repeated on the contralateral side.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-19', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-07-31', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from injection of LA to the first postoperative analgesic request', 'timeFrame': 'UP TO 1 HOURE', 'description': '(duration of the block).'}], 'secondaryOutcomes': [{'measure': 'heart rate', 'timeFrame': 'up to 24 hours', 'description': 'beat/min'}, {'measure': 'VAS', 'timeFrame': 'up to 24 hours', 'description': '0 No Pain 1-3 Mild Pain (nagging, annoying, interfering little with ADLs) 4-6 Moderate Pain (interferes significantly with ADLs) 7-10 Severe Pain (disabling; unable to perform ADLs)'}, {'measure': 'perform SCAB', 'timeFrame': 'UP TO 1 HOURE', 'description': 'The mean time needed to perform SCAB'}, {'measure': 'total nalbuphine consumption', 'timeFrame': 'up to 24 hours', 'description': 'total nalbuphine consumption'}, {'measure': 'Incidence of complications', 'timeFrame': 'up to 24 hours', 'description': 'complications'}, {'measure': 'mean arterial blood pressure', 'timeFrame': 'up to 24 hours', 'description': 'mmHg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spermatic Cord Block', 'Magnesium Sulfate', 'Dexmedetomidine'], 'conditions': ['Spermatic Cord Block']}, 'descriptionModule': {'briefSummary': 'Using the spermatic cord block has been of great advantage, as it has been cost saving, efficient technique whether used inon its own or combination with a sedative or . Furthermore, it provides minimal cardiac risks, early case ambulation, satisfactory postoperative pain control, as well as a reduced hospital stay and cost. one of the major drawbacks of spermatic cord block is being a single injection technique, leading to a short postoperative analgesia duration. So, to overcome this flaw some adjuvants were proven to prolong the analgesia duration as Dexmetedomidine (Dex), and magnesium.', 'detailedDescription': 'The technique of the spermatic cord block was first described in the 1960s by Earle AS.Using the spermatic cord block has been of great advantage, as it has been cost saving, efficient technique whether used inon its own or combination with a sedative or . Furthermore, it provides minimal cardiac risks, early case ambulation, satisfactory postoperative pain control, as well as a reduced hospital stay and cost. one of the major drawbacks of spermatic cord block is being a single injection technique, leading to a short postoperative analgesia duration. So, to overcome this flaw some adjuvants were proven to prolong the analgesia duration as Dexmetedomidine (Dex), and magnesium.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'the operation only in male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged from 18 to 60 years.\n* ASA I-II.\n* Undergoing Testicular Sperm Extraction Surgery.\n* BMI from 18.5 to 30 kg/m2\n\nExclusion Criteria:\n\n* Patient refusal\n* Contraindications to regional anesthesia (bleeding disorders e.g. INR\\>1.5, PC\\<70%, platelet count\\<100 × 109, use of any anti-coagulants, local infection, etc.).\n* Known allergy to local anesthetics.\n* ASA III-IV.\n* Patients aged less than 18 or more than 60.\n* Body mass index \\>35.\n* Patients with difficulty in evaluating their level of pain.'}, 'identificationModule': {'nctId': 'NCT04498351', 'briefTitle': 'Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine for Augmenting Analgesia and Anesthesia in Ultrasound Guided Spermatic Cord Block For Testicular Sperm Extraction Surgery', 'orgStudyIdInfo': {'id': 'N-19-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'cotrol group', 'interventionNames': ['Drug: Control Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine group', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'magnesium sulphate group', 'interventionNames': ['Drug: magnesium sulphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine and magnesium sulphate group', 'interventionNames': ['Drug: Dexmedetomidine and magnesium sulphate']}], 'interventions': [{'name': 'Control Test', 'type': 'DRUG', 'description': 'Spermatic cord block by18ml levobupivacaine 0.5% plus 2 ml normal saline in total volume of 20 ml.\n\nThe procedure is repeated on the contralateral side.', 'armGroupLabels': ['cotrol group']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 1 μg/kg dexmedetomidine in 2 ml in total volume of 20 ml The procedure is repeated on the contralateral side.', 'armGroupLabels': ['dexmedetomidine group']}, {'name': 'Dexmedetomidine and magnesium sulphate', 'type': 'DRUG', 'description': 'Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 1 μg/kg dexmedetomidine and 100 mg magnesium sulphate in 2 ml in total volume of 20 ml .\n\nThe procedure is repeated on the contralateral side.', 'armGroupLabels': ['dexmedetomidine and magnesium sulphate group']}, {'name': 'magnesium sulphate', 'type': 'DRUG', 'description': 'Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 100 mg magnesium sulphate in 2 ml in total volume of 20 ml', 'armGroupLabels': ['magnesium sulphate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11451', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Cairo University.', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'mohamad abdulfatah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecture'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'still working'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia, Pain management and Surgical ICU', 'investigatorFullName': 'Amr Samir Wahdan', 'investigatorAffiliation': 'Cairo University'}}}}