Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-02 @ 11:22 AM
Study NCT ID:
NCT01921361
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2013-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-12', 'studyFirstSubmitDate': '2013-08-03', 'studyFirstSubmitQcDate': '2013-08-12', 'lastUpdatePostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shivering score', 'timeFrame': '1 day (From start of anaesthesia till discharge from the recovery room )'}], 'secondaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': '1 day (From start of anaesthesia till discharge from the recovery room )', 'description': 'non invasive blood pressure measured'}, {'measure': 'heart rate', 'timeFrame': '1 day (From start of anaesthesia till discharge from the recovery room )'}, {'measure': 'core temperature', 'timeFrame': '1 day (From start of anaesthesia till discharge from the recovery room )', 'description': 'lower than 36 celsius degree was accepted as hypothermia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Shivering', 'Dexmedetomidine', 'Spinal anesthesia'], 'conditions': ['Perioperative/Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery.', 'detailedDescription': 'The design of the study includes three study groups done in random order. The groups are as follows: 1) Control group received 15 mg levobupivacaine intrathecally and intravenous 0.9% sodium chloride; 2) Intravenous group received 15 mg levobupivacaine intrathecally and intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) Intrathecal group received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9% sodium chloride.\n\nThroughout the study period,shivering scores, tympanic temperature were recorded, heart rate were measured continuously using an electrocardiogram; blood pressure was determined oscillometrically at 5 min intervals at the ankle. In case heart rate decreased by more than 30% of the baseline atropin received and blood pressure decreased 30% of the baseline effedrin received.\n\nSide effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded peroperatively in the operating room and postanesthetic care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-65 y/o patients\n* American Society of Anesthesiologists' physical status class I-II\n* Scheduled for the spinal anesthesia\n\nExclusion Criteria:\n\n* Patients who have the body temperature over 37.3 celsius degree\n* Pregnants\n* Known allergies to the study drugs\n* Contraindication to spinal anesthesia"}, 'identificationModule': {'nctId': 'NCT01921361', 'briefTitle': 'The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'B.30.2.ERC.0.01.00.01/27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous', 'description': 'Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous dexmedetomidine (dexmedetomidine diluted 1mcg/ml and than 1ml/kg/10 minutes and 0.5 ml/kg/hour infusion)', 'interventionNames': ['Drug: Levobupivacaine', 'Drug: Dexmedetomidine', 'Drug: sodium chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intrathecal', 'description': 'Intrathecal (3 ml) 15 mg levobupivacaine + (0.3 ml) 3 mcg dexmedetomidine (dexmedetomidine diluted 10 mcg/ml) and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion)', 'interventionNames': ['Drug: Levobupivacaine', 'Drug: Dexmedetomidine', 'Drug: sodium chloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion).', 'interventionNames': ['Drug: Levobupivacaine', 'Drug: sodium chloride']}], 'interventions': [{'name': 'Levobupivacaine', 'type': 'DRUG', 'otherNames': ['Chirocaine, 0.5%, 10 ml, Abbott'], 'description': 'Intrathecal 3ml (15 mg)', 'armGroupLabels': ['Control', 'Intrathecal', 'Intravenous']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex, 100 mcg/ml, Abbott'], 'description': 'Intrathecal 3 microgram (diluted 1/10, 0.3 ml)', 'armGroupLabels': ['Intravenous']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex, 100 mcg/ml, Abbott'], 'description': 'Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml)', 'armGroupLabels': ['Intrathecal']}, {'name': 'sodium chloride', 'type': 'DRUG', 'otherNames': ['0.9 Sodium chloride'], 'description': 'Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups.', 'armGroupLabels': ['Control', 'Intrathecal', 'Intravenous']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Resul Altuntas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TC Erciyes University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'RESUL ALTUNTAS', 'investigatorAffiliation': 'TC Erciyes University'}}}}