Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT01377259
Status:
UNKNOWN
Last Update Posted:
2011-06-21
First Post:
2008-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-20', 'studyFirstSubmitDate': '2008-09-14', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['changes', 'tissue', 'oxygenation', 'saturation', 'between', 'upper', 'lower', 'extremities', 'patients', 'Adverse Effect', 'Spinal and Epidural'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Neuraxial anesthesia affords a less interventional way to desensitization of the lower body for surgical procedures. After introduction of neuraxial anesthesia, vasodilatation of body part below the anesthetic level is theoretically appeared as the sympathetic nerve efferent is blocked. The vasodilatation effect is related to hypotension, hypothermia, shivering and the response of volume redistribution. It is believed that vasodilatation leads to better regional tissue perfusion and better regional tissue oxygenation. Previous reports of laser doppler flowmetry and thermography showed their effectiveness on monitoring blocked level but they were not easily available in the operation room. Recently Near-infrared spectroscopy(NIRS) demonstrates real-time tissue oxygen saturation(rSO2) which is applied generally in non-invasive brain oximeter. We use NIRS in spinal anesthesia to monitor the tissue oxygenation change over the upper and lower limbs during the induction of neuraxial anesthesia.', 'detailedDescription': 'In patients who were planned to receive an operation with intrathecal anesthesia, NIRS (INVOS Cerebral Oximeter Model 5100B; Somanetics, Troy, MI, USA) with two adhesive patches was used to monitor rSO2. One patch was applied over the biceps brachii muscle,(the body part above the anaesthetic level), and the other patch was applied over the medial side of the gastrocnemius muscle of the non-surgical leg,(the body part below the anaesthetic level). In both extremities, rSO2 was monitored continuously and recorded every minute from before intrathecal bupivacaine injection until 15 min after injection. Isobaric bupivacaine 0.5% 10-15 mg was injected intrathecally and the level of anaesthesia was examined 10 min later by loss of cold sensation to alcohol swab by an anaesthetist not involved in the study. the changes of rSO2 of upper and lower extrimities were recorded and analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who receive operations under spinal anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who receive operations under spinal anesthesia\n\nExclusion Criteria:\n\n* neurological, cardiovascular diseases'}, 'identificationModule': {'nctId': 'NCT01377259', 'briefTitle': 'The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': '200808010R'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1Tissue oxygenation change', 'description': 'Spinal anesthesia may result different changes of tissue oxygenation in blocked area ( upper extrimities ) and non-blocked area ( lower extrimities). The changes of tissue oxygenation saturation between upper and lower extremities in patients under spinal anesthesia for orthopedic surgery', 'interventionNames': ['Other: tissue oxygen saturation, spinal anesthesia']}, {'label': '2Tissue oxygenation change', 'description': 'The changes of tissue oxygenation saturation between upper and lower extremities in patients under spinal anesthesia for cesarean section', 'interventionNames': ['Other: tissue oxygen saturation, spinal anesthesia']}], 'interventions': [{'name': 'tissue oxygen saturation, spinal anesthesia', 'type': 'OTHER', 'otherNames': ['NIRS model - INVOS(Somanetics) 5100B Cerebral Oximetry'], 'description': 'regional tissue oxygen saturation(rSO2)detected over upper and lower extremities before and after spinal anesthesia', 'armGroupLabels': ['1Tissue oxygenation change', '2Tissue oxygenation change']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'ya-jung cheng', 'role': 'CONTACT', 'email': 'chengyj@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '62158'}], 'facility': 'National Taiwan University Hospital'}], 'centralContacts': [{'name': 'Ya-jung Cheng, MD.,PhD.', 'role': 'CONTACT', 'email': 'chengyj@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '62158'}], 'overallOfficials': [{'name': 'ya-jung cheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'department of anesthesiology, national taiwan university nospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cheng ya-jung', 'oldOrganization': 'Department of Anesthesiology, National Taiwan University Hospital'}}}}