Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT02530632
Status:
UNKNOWN
Last Update Posted:
2016-04-13
First Post:
2015-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of General Anesthesia on Microcirculation of Central and Peripheral Soft Tissue: a Comparison of Inhalational and Intravenous Anesthetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], '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': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2015-08-19', 'lastUpdatePostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Somatic saturation', 'timeFrame': 'during surgery, approximately 2-4 hr', 'description': 'Change of somatic saturation measured by NIRS'}], 'secondaryOutcomes': [{'measure': 'Body temperature', 'timeFrame': 'during surgery, approximately 2-4 hr', 'description': 'Nasal and peripheral temperature'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['microperfusion', 'temperature', 'near-infrared spectroscopy', 'anesthesia', 'total intravenous anaesthesia'], 'conditions': ['Microcirculatory Effects of Anesthesia', 'Inhalation and Intravenous Anesthesia']}, 'descriptionModule': {'briefSummary': 'Effects of different general anesthetics on peripheral microcirculation.', 'detailedDescription': 'Human keep body temperature in a narrow range by a variety of regulatory mechanism. Peripheral thermal receptors send signals to central nervous system which regulate body temperature via peripheral effectors, such as vasoconstriction, vasodilatation, shivering, sweating and etc. In patients undergoing general anesthesia, the regulatory mechanism is altered. General anesthesia changes blood distribution in the body, the metabolic rate of muscle, threshold of thermal regulation in the brain and etc, so that heat distribution and microcirculation condition will also change. In this study, near-infrared spectroscopy (NIRS) is used to measure the microcirculatory condition. NIRS is a non-invasive continuous measurement to detect tissue saturation with the method of different wavelength of near-infrared. General anesthesia with inhalational sevoflurane and intravenous propofol is separated into 2 groups. Because of different mechanism of general anesthesia of these 2 anesthetics, different physiologic response may occur. Body temperature and somatic saturation are compared in each group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Breast surgeries under general anesthesia\n2. BMI 18.5\\~30\n\nExclusion Criteria:\n\n1. Cardiac disease\n2. Lung disease\n3. Renal disease\n4. Neurological disease\n5. Autonomic nervous system dysfunction'}, 'identificationModule': {'nctId': 'NCT02530632', 'briefTitle': 'The Effects of General Anesthesia on Microcirculation of Central and Peripheral Soft Tissue: a Comparison of Inhalational and Intravenous Anesthetics', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Effects of General Anesthesia on Microcirculation of Central and Peripheral Soft Tissue: a Comparison of Inhalational and Intravenous Anesthetics', 'orgStudyIdInfo': {'id': '201504089RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane anesthesia', 'description': 'Anesthesia maintained with inhalational sevoflurane', 'interventionNames': ['Drug: Sevoflurane', 'Procedure: General anesthesia induction']}, {'type': 'EXPERIMENTAL', 'label': 'Propofol anesthesia', 'description': 'Anesthesia maintained with intravenous propofol continuous infusion', 'interventionNames': ['Drug: Propofol', 'Procedure: General anesthesia induction']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'General anesthesia maintained with intravenous propofol infusion', 'armGroupLabels': ['Propofol anesthesia']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'General anesthesia maintained with inhalational sevoflurane', 'armGroupLabels': ['Sevoflurane anesthesia']}, {'name': 'General anesthesia induction', 'type': 'PROCEDURE', 'description': 'Induce routine of general anesthesia, including propofol 1-3mg/kg, fentanyl 1-3mcg/kg, cisatracurium 0.2-0.3mg/kg.', 'armGroupLabels': ['Propofol anesthesia', 'Sevoflurane anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shou-Zen Fan', 'role': 'CONTACT', 'email': 'shouzen@gmail.com', 'phone': '886-23123456', 'phoneExt': '65523'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Cheng-Han Yen', 'role': 'CONTACT', 'email': 'ozone0924@gmail.com', 'phone': '+886972653387'}, {'name': 'Cheng-Han Yen', 'role': 'CONTACT', 'phone': '+886972653387'}], 'overallOfficials': [{'name': 'Shou-Zen Fan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}