Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-01-16 @ 2:41 AM
Study NCT ID:
NCT02948920
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004809', 'term': 'Ephedrine'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-05', 'studyFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tympanic temperature', 'timeFrame': '120 minutes', 'description': 'Diffference of changes in tympanic membrane temperature at time points compare with baseline (before spinal block) between two groups'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '120 minutes', 'description': 'Difference of changes of blood pressure at time points compare with baseline (before spinal block) between two groups'}, {'measure': 'Shivering', 'timeFrame': '120 minutes', 'description': 'After performing spinal anesthesia in 120 minutes duration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ephedrine', 'core temperature', 'tympanic temperature', 'heat loss', 'spinal anesthesia', 'neuraxial', 'hypothermia', 'shivering'], 'conditions': ['Body Temperature Changes']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Thanist Pravitharangul, Wirakorn Koopinpaitoon, Rungruedee Kraisen, Rojnarin Komonhirun. Ephedrine and propofol for induction of general anesthesia can decrease intraoperative hypothermia in patients undergoing plastic and breast surgery: a randomized, controlled trial. Asian Biomedicine Vol. 9 No. 3 June 2015; 379 - 385'}]}, 'descriptionModule': {'briefSummary': 'A prospective double-blinded randomized controlled study to determine efficacy of ephedrine in preserving core temperature in patients under neuraxial spinal anesthesia for knee and ankle arthroscopic surgery.', 'detailedDescription': 'To determine the effect of ephedrine on preserving core temperature (tympanic) when given at finishing of local anesthetic administration for spinal neuraxial anesthesia comparing to normal saline (120 minutes period)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing knee or ankle arthroscopic surgery under spinal block at department of orthopaedic Ramathibodi Hospital\n* BMI 17-30 kg/m2\n* ASA physical status 1-3\n* Age 18-70\n* Last oral intake more than 6 hours (2 hours for water)\n* Consent form acquired\n\nExclusion Criteria:\n\n* Patient who are contraindicated for spinal block\n* Anesthesia level higher than T4 or lower than T10\n* Tympanic temperature more than 37.5 or less than 35.5 degrees Celsius\n* Otitis or other ear infection\n* Patients who receive alpha adrenergic blocker or beta adrenergic blocker\n* Initial blood pressure presenting in operating theater 140 90 mmHg repeat after rest 5 minutes\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT02948920', 'briefTitle': 'Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery', 'orgStudyIdInfo': {'id': '07-59-07'}, 'secondaryIdInfos': [{'id': 'TCTR20161017007', 'type': 'REGISTRY', 'domain': 'Thai Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ephedrine', 'description': 'Intravenous 9 mg of ephedrine (3 ml) given at finishing local anesthetic administration for spinal anesthesia', 'interventionNames': ['Drug: Ephedrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NSS', 'description': 'Intravenous normal saline 3 ml given at finishing local anesthetic administration for spinal anesthesia', 'interventionNames': ['Drug: NSS']}], 'interventions': [{'name': 'Ephedrine', 'type': 'DRUG', 'otherNames': ['Experimental'], 'description': '9 mg of ephedrine (3 ml)', 'armGroupLabels': ['Ephedrine']}, {'name': 'NSS', 'type': 'DRUG', 'otherNames': ['Control'], 'description': '3 ml of normal saline', 'armGroupLabels': ['NSS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Anesthesiology, Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Thanist Pravitharangul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Ramathibodi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Thanist Pravitharangul', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}