Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-07 @ 10:14 PM
Study NCT ID:
NCT03086694
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2017-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal-Directed Fluid Therapy for Patients Undergoing Oro-Maxillofacial Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2017-02-06', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood loss measurement', 'timeFrame': '10hrs', 'description': 'to maintain low blood pressure (MAP \\> 55mmHg) to limit blood loss'}], 'secondaryOutcomes': [{'measure': 'assessment of inappropriate fluid infusion', 'timeFrame': '10hours', 'description': 'count the fluid given by stroke volume variation but fixed time administration'}, {'measure': 'postoperative adverse events', 'timeFrame': '2 days', 'description': 'adequate medications to maintain low stable BP to decrease tissue edematous change'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oromaxillofacial surgery', 'nasotracheal intubation', 'stroke volume variation'], 'conditions': ['Blood Pressure, Low']}, 'referencesModule': {'references': [{'pmid': '26460721', 'type': 'BACKGROUND', 'citation': 'Lee MC, Tseng KY, Shen YC, Lin CH, Hsu CW, Hsu HJ, Lu IC, Cheng KI. Nasotracheal intubation in patients with limited mouth opening: a comparison between fibreoptic intubation and the Trachway(R). Anaesthesia. 2016 Jan;71(1):31-8. doi: 10.1111/anae.13232. Epub 2015 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'Orthognathic surgery, one kind of Oro-maxillofacial surgery, is a complicate surgery that undergoes several hours with nasotracheal intubation general anesthesia. To limit blood loss during operation, the patients are often under intentional hypotension. However, the intentional hypotension may confuse with hypovolemic induced low blood pressure. The hypothesis is using flotrac (to measure stroke volume variation) to keep the patients hemodynamics stable under Tridil and propofol infusion and avoid over-infusion of crystalloid or colloid and prevent hypovolemia induced postoperative nausea and vomiting.', 'detailedDescription': 'Orthognathic surgery, one kind of oro-maxillofacial surgery, is a complicated surgery that undergoes several hours with nasotracheal intubation general anesthesia. Patients without premedication undergo orthognathic surgery with nasotracheal intubation general anesthesia.\n\nPatients without premedications Monitoring of patients with entropy for consciousness, ECG, with noninvasive BP and invasive blood pressure through redial artery, train-of-four monitor, target controlled infusion of propofol, infusion Tridil, and sevoflurane for mainly anesthesia maintenance. Ventilator setting as volume control (8-12ml/kg), frequency respiratory rate (8-12/min), I/E ratio: 1/2, positive end expiratory pressure: 4 mmHg, Fraction inspiratory O2: 60%.\n\nTo maintain the MAP \\>60-55 mmHg, urine output 0.5-1ml/kg, and body core temperature \\> 36 Celsius degree.\n\nClosely observation of patients postoperatively for adverse events or complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who need to operate for abnormal face or abnormal teeth biting', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergo orthognathic surgery, ASA I\\~III, 20 to 65 years old, no mouth limitation\n\nExclusion Criteria:\n\n* ankylosing spondylitis, limited mouth opening \\< 3 cm, liver or renal disease, obese patients (BMI\\>35kg/m2), patients refused'}, 'identificationModule': {'nctId': 'NCT03086694', 'briefTitle': 'Goal-Directed Fluid Therapy for Patients Undergoing Oro-Maxillofacial Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'orgStudyIdInfo': {'id': 'KMUHIRB-E(II)_20160110'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group surgery', 'description': 'using medications to maintain low stable blood pressure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80765', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'kuang I Cheng, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}