Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT04142502
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2019-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Propofol group: propofol infusion as sedation drug Dexmedetomidine group: dexmedetomidine infusion as sedation drug'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2019-10-25', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serial heart rate variability', 'timeFrame': '40 minutes (before entering the operating room ~ 20 minutes after starting sedation', 'description': 'Serial change of frequency domain results from EKG RR interval Baseline: before entering the operating room T0: Preinduction T1: 10 minutes after spinal anesthesia T2: 10 minutes after starting sedation T3: 20 minutes after starting sedationi\n\nFrequency domain results Total power (ms2) Low frequency (ms2) High frequency (ms2) LF/HF ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal anesthesia', 'autonomic nervous system', 'dexmedetomidine', 'propofol'], 'conditions': ['Spinal Anesthesia', 'Autonomic Nervous System']}, 'descriptionModule': {'briefSummary': 'Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases parasympathetic activity and increases sympathetic activity. These imbalance of autonomic nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which are used for sedation during spinal anesthesia, also affect autonomic nervous system, but the exact effects are not well known. The purpose of this study is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia.', 'detailedDescription': 'Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases parasympathetic activity and increases sympathetic activity. These imbalance of autonomic nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which are used for sedation during spinal anesthesia, also affect autonomic nervous system but the exact effects are not well known. Moreoever, the effect of spinal anesthesia combined with sedation agent on autonomic nervous system has not been evaluated. The purpose of this study is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia. The current study is prospective randomized pilot study. Patients are assigned to propofol group and dexmedetomidine group. Using electrocardiaogram analysis, the change of autonomic nervous system will be measured from preoperative to end of surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20\\~60 years old\n* Scheduled lower extremity surgery under spinal anesthesia\n\nExclusion Criteria:\n\n* Arryhthmia\n* Uncooperative patients\n* Diabetes\n* On medication: beta blocker, psychiatric medicine\n* Thyroid function abnormality'}, 'identificationModule': {'nctId': 'NCT04142502', 'acronym': 'ANS', 'briefTitle': 'Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia: Pilot Study', 'orgStudyIdInfo': {'id': 'MED-INT-19-350'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol group', 'description': 'Using propofol as a sedation drug Infusion rate control Effect site concentration 0.3\\~1.0 mg/ml using target concentration infusion Bispectral index 60\\~80', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine group', 'description': 'Using dexmedetomidine as a sedation drug First 10 minutes 1.0 mcg/kg loading After 10 minutes 0.3-1.0 mcg/kg/hr maintenance Bispectral index 60\\~80', 'interventionNames': ['Drug: Dexmedetomidin']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['FRESofol MCT inj 1% 500mg/50ml, Fresenium Kabi'], 'description': 'Propofol as a sedation drug', 'armGroupLabels': ['Propofol group']}, {'name': 'Dexmedetomidin', 'type': 'DRUG', 'otherNames': ['Medex inj, 200mcg/2ml, ILSUNG'], 'description': 'Dexmedetomidine as a sedation drug', 'armGroupLabels': ['Dexmedetomidine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou university school of medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'In Kyong Yi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If a reasonable personal request exist, the investigators can share the data personally.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ilsung Pharmaceuticals CO.,LTD.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'In-kyong Yi', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}