Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-02 @ 4:45 PM
Study NCT ID:
NCT02382432
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2015-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine in Post Spinal Anesthesia Shivering
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008614', 'term': 'Meperidine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-03', 'studyFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'heart rate', 'timeFrame': '6 hours after study drug injection', 'description': 'find for bradycardia or tachycardia'}], 'primaryOutcomes': [{'measure': 'Shivering response rate (%)', 'timeFrame': '10 minutes', 'description': 'complete cessation of shivering activity within 10 minutes after study drug injection'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '6 hours after study drug injection', 'description': 'find for systolic hypotension, hypertension'}, {'measure': 'sedation', 'timeFrame': '6 hours after study drug injection', 'description': "using an Observer's Assessment of Alertness/Sedation Scale (OAA/SS) (where 5 = Responds readily to name spoken in normal tone, 4 = Lethargic response to name spoken in normal tone, 3 = Responds only after name is spoken loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Does not respond to mild prodding or shaking)."}, {'measure': 'peripheral arterial saturation', 'timeFrame': '6 hours after study drug injection', 'description': 'find for hypoxia'}, {'measure': 'diastolic blood pressure', 'timeFrame': '6 hours after study drug injection', 'description': 'find for diastolic hypertension or hypotension'}, {'measure': 'Postoperative adverse events', 'timeFrame': '24 hours postoperative', 'description': 'postoperative nausea and vomiting, urine retention, post dural puncture headache ect.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'dexmedetomidine', 'pethidine', 'shivering', 'spinal'], 'conditions': ['Shivering Caused by Spinal Anesthesia']}, 'referencesModule': {'references': [{'pmid': '27228512', 'type': 'DERIVED', 'citation': 'Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine.', 'detailedDescription': 'Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has been shown to be one of the most effective treatments.The α-2 receptor agonists are another important class of anti-shivering drugs that, unlike meperidine, produce little respiratory depression.\n\nDexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologist class I or II scheduled for elective minor lower abdominal operations under spinal anesthesia for an anticipated duration of \\>60 and \\<180 min. (e.g. inguinal herniorRaphy, umbilical hernia repair) who developed shivering during the intra or postoperative period\n\nExclusion Criteria:\n\n* Patients with BMI\\>30 kg /m2\n* Initial body temperature \\>38 C or \\<36 C and those with a history of convulsions\n* Multiple allergies\n* Thyroid disease\n* Parkinson's disease\n* Dysautonomia\n* Raynaud's syndrome\n* Hypertension\n* Coronary artery disease or other cardio-respiratory or neuromuscular pathology\n* Middle ear pathology\n* A known history of alcohol use\n* Treatment with sedative hypnotic agents or vasodilators\n* Having contraindications to spinal anesthesia"}, 'identificationModule': {'nctId': 'NCT02382432', 'briefTitle': 'Dexmedetomidine in Post Spinal Anesthesia Shivering', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Clinically Controlled Dose-finding Study.', 'orgStudyIdInfo': {'id': 'IRB00008718'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pethidine 0.4mg/kg iv', 'description': 'interventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished.', 'interventionNames': ['Drug: Pethidine 0.4mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DEX. I', 'description': 'Interventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DEX. II', 'description': 'Interventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DEX III', 'description': 'Interventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Pethidine 0.4mg/kg', 'type': 'DRUG', 'otherNames': ['Meperidine'], 'description': '2ml intravenous bolus slowly injected in 2minutes.', 'armGroupLabels': ['Pethidine 0.4mg/kg iv']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': '2ml intravenous bolus slowly injected in 2minutes', 'armGroupLabels': ['DEX III', 'DEX. I', 'DEX. II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '715715', 'city': 'Asyut', 'state': 'Assiut Governorate', 'country': 'Egypt', 'facility': 'Assiut university hospital, Assiut, Egypt', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Hala S Abdel-Ghaffar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assistant professor in anesthesia, faculty of medicine, Assiut university, Assiut, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor in anesthesia department, faculty of medicine, Assiut university', 'investigatorFullName': 'Hala Saad Abdel-Ghaffar', 'investigatorAffiliation': 'Assiut University'}}}}