Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-04-16 @ 11:49 AM
Study NCT ID:
NCT03212495
Status:
COMPLETED
Last Update Posted:
2018-01-11
First Post:
2017-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-articular Dexmedetomidine Versus Neostigmine After Knee Arthroscopy (a Comparative Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D009388', 'term': 'Neostigmine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D050338', 'term': 'Phenylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': ', Patients were randomly allocated (using random table assignment) into two groups to receive one of the following intra-articular solutions (prepared by an individual not involved in the study) which were injected into the knee joint through the cannular sheath after withdrawal of camera, by the orthopaedic surgeon (who was also unaware of the nature of the study drugs) before the arthroscope removed.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly allocated to one of two groups each including 50 patients; the group received either intraarticular dexametomidine or neostigmine .'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-10', 'studyFirstSubmitDate': '2017-07-07', 'studyFirstSubmitQcDate': '2017-07-07', 'lastUpdatePostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '36 hours after the end of the surgery.', 'description': 'visual analogue pain scale'}], 'secondaryOutcomes': [{'measure': 'nausea,vomiting', 'timeFrame': '36 hours after the end of the surgery.', 'description': 'nausea and vomiting scales'}, {'measure': 'sedation', 'timeFrame': '36 hours after the end of the surgery.', 'description': 'Ramsay sedation score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee arthroscopy', 'dexmedetomidine', 'neostigmine'], 'conditions': ['Knee Injuries']}, 'referencesModule': {'references': [{'pmid': '18567675', 'type': 'RESULT', 'citation': 'Al-Metwalli RR, Mowafi HA, Ismail SA, Siddiqui AK, Al-Ghamdi AM, Shafi MA, El-Saleh AR. Effect of intra-articular dexmedetomidine on postoperative analgesia after arthroscopic knee surgery. Br J Anaesth. 2008 Sep;101(3):395-9. doi: 10.1093/bja/aen184. Epub 2008 Jun 20.'}, {'pmid': '16835255', 'type': 'RESULT', 'citation': 'Bondok RS, Abd El-Hady AM. Intra-articular magnesium is effective for postoperative analgesia in arthroscopic knee surgery. Br J Anaesth. 2006 Sep;97(3):389-92. doi: 10.1093/bja/ael176. Epub 2006 Jul 11.'}, {'pmid': '15329580', 'type': 'RESULT', 'citation': "Ebert T, Maze M. Dexmedetomidine: another arrow for the clinician's quiver. Anesthesiology. 2004 Sep;101(3):568-70. doi: 10.1097/00000542-200409000-00003. No abstract available."}]}, 'descriptionModule': {'briefSummary': 'Knee arthroscopy is a minimally invasive day case procedure which may be done for diagnosis, meniscectomy or debridement. Arthroscopic surgery is associated with a variable degree of postoperative pain, which is caused by an irritation of free nerve endings of the synovial tissue, anterior fat pad, and joint capsule due to surgical excision and resection', 'detailedDescription': 'Many studies were done using different intra-articular agents as local anesthetics, opioids, ketamine and alfa2- adrenergic agonists for prevention and treatment of pain after knee surgeries.\n\nDexmedetomidine is a potent and highly selective alfa2-adrenoreceptor agonist. It has sedative-hypnotic, anxiolytic, analgesic, anesthetic and sympatholytic effects. Intra-articular dexmedetomidine was used in several studies to enhance postoperative analgesia after knee arthroscopy with an increased time to first analgesic request and a decreased need for postoperative analgesia Neostigmine is an anticholinesterase and also has antinociceptive effects when administered intrathecally or peripherally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged above 18 years\n* scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia\n\nExclusion Criteria:\n\n* Absolute or relative contraindications for intrathecal anaesthesia,\n* Allergy for the studied drugs.\n* Patients having history of cardiovascular, cerebrovascular, and respiratory diseases,\n* Patients receiving chronic pain treatment or hypertension treated with alfa methyldopa, clonidine or beta adrenergic blockers were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03212495', 'briefTitle': 'Intra-articular Dexmedetomidine Versus Neostigmine After Knee Arthroscopy (a Comparative Study)', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between Intra-articular Dexmedetomidine and Neostigmine as Adjuvant Analgesics After Knee Arthroscopy', 'orgStudyIdInfo': {'id': 'dexmedetomidine vs neostigmine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine (D group)', 'description': 'intraarticular administration of dexmedetomidine at the end of surgery', 'interventionNames': ['Drug: dexamedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'neostigmine (N group)', 'description': 'intraarticular administration of neostigmine at the end of surgery.', 'interventionNames': ['Drug: neostigmine']}], 'interventions': [{'name': 'dexamedetomidine', 'type': 'DRUG', 'otherNames': ['precedex', 'dexamedetomidine Hcl injection'], 'description': 'intraarticular injection of 1µg/kg dexametomidine +18ml 0.25%bubivacaine in a total volume of 20 ml.', 'armGroupLabels': ['dexmedetomidine (D group)']}, {'name': 'neostigmine', 'type': 'DRUG', 'otherNames': ['prostigmine'], 'description': 'intraarticular injection of 0.5mg/dose neostigmine +18ml 0.25%bubivacaine in a total volume of 20 ml.', 'armGroupLabels': ['neostigmine (N group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut governorate', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ghada Mohammed AboelFadl', 'investigatorAffiliation': 'Assiut University'}}}}