Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06259760
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D007741', 'term': 'Labetalol'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D012457', 'term': 'Salicylamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urine biomarkers assessment, urine output, and blood Creatinine from participants undergoing Orthognathic surgery.', 'timeFrame': 'intraoperative and postoperative stages, assessed up to 24 hours', 'description': 'Record blood and urine biomarkers, and urine output after operation'}, {'measure': 'permitted hypotension during surgery', 'timeFrame': 'intraoperative 2-6 hours', 'description': 'assess intraoperative blood loss and the dosage of hypotensive medications to decrease intra-operative bleeding as patient undergoing oromaxillofacial surgery, intentional hypotension is allowed. however, adequate depth of anesthesia, proper cardiac output, respiratory parameters, temperatures should be monitored'}, {'measure': 'consumption of inhaled and intravenous anesthetics', 'timeFrame': 'intraoperative 2-6 hours', 'description': 'to maintain adequate depth of anesthesia during intentional hypotension, consumptions of inhaled and intravenous anesthetics are calculated'}], 'secondaryOutcomes': [{'measure': 'time to successfully extubate the nasotracheal tube after anesthesia', 'timeFrame': 'from the end of surgery to the post-anesthesia care, assessed up to one hour', 'description': 'early extubation allowable'}, {'measure': 'safely discharged from post-anesthesia care unit (postoperative recovery room)', 'timeFrame': '2 hours', 'description': 'as calculating the time from patient is delivered to postoperative recovery room to be safely discharged from recovery room by using the aldrete scores (activities level, respiration, circulation, conscious level, oxygenation) full back to pre-operative level or ten scores.'}, {'measure': 'side effects and adverse events', 'timeFrame': 'intraoperative and postoperative stages, assessed up to 48 hours', 'description': 'records any abnormal surgical or anesthesia related findings during this admission'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'orthognathic surgery', 'general anesthesia', 'prospective analysis', 'intentional hypotension'], 'conditions': ['Acute Kidney Injury (Nontraumatic)', 'Hypotension Drug-Induced']}, 'descriptionModule': {'briefSummary': 'This project investigates intentionally hypotensive management such as NTG (nitroglycerin) or NTG+Trandate during general anesthesia in patients undergoing orthognathic surgery. Throughout the entire surgical procedure, blood biochemical and urine monitoring will be conducted. Serum creatinine (Cr) levels, urine analysis, and perioperative monitoring will be utilized as indicators for assessing renal function during the surgery. The objective is to assess its potential renal injury and identify early risk factors for acute kidney injury (AKI). Timely recognition of these factors will allow for the implementation of appropriate intervention strategies, aiding in the prevention of postoperative acute kidney injury. This approach contributes to achieving the goals of Enhanced Recovery After Surgery (ERAS) for surgical patients, promoting faster postoperative recovery.', 'detailedDescription': "Orthognathic surgery is currently a common procedure in oral and maxillofacial surgery. The facial region is composed of a complex and dense vascular network, requiring precise, accurate, and delicate surgical techniques on both hard and soft tissues. During intraoral procedures, the surgical field may be limited, making the management of surgical bleeding challenging. Controlled hypotension or hypotensive anesthesia is often employed during major maxillofacial surgeries to optimize conditions. Lowering blood pressure is advantageous as it helps reduce overall blood loss and improves the surgeon's visibility. Therefore, maintaining stable blood pressure within the ideal range during the surgical process is a critical anesthesia objective.\n\nThis research emphasizes the prevention of acute kidney injury (AKI) in patients undergoing orthognathic surgery with intentional hypotension during general anesthesia. The goal is to detect the potential renal damage at an early stages, before a significant decline in kidney function occurs, thereby reducing the likelihood of acute kidney injury."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients without obviously systemic diseases who presentation of abnormal oro-maxillofacial anatomy needs to be corrected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* America society anesthesiologist classification class I to II patients undergoing oro-maxillo-facial surgery\n* unlimited mouth opening\n\nExclusion Criteria:\n\n* patients with arthritis with limited mouth opening\n* persistent liver dysfunction\n* chronic renal insufficiency\n* body mass index ≧35 kg/m2.\n* past history of malignant hyperthermia or personal or family history\n* diabetes with insulin treatment\n* essential hypertension without controlled'}, 'identificationModule': {'nctId': 'NCT06259760', 'briefTitle': 'AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Incidence and Risk Factors Analysis of Acute Kidney Injury (AKI) After Intentional Hypotensive Anesthesia in Orthognathic Surgery Patients Following Enhanced Recovery After Surgery (ERAS) Guidelines', 'orgStudyIdInfo': {'id': 'KMUHIRB-E(I)-20240015'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nitroglycerin', 'type': 'DRUG', 'otherNames': ['labetalol'], 'description': 'during surgery, the patient received nitroglycerin infusion or nitroglycerin with labetalol to decrease blood pressure and to decrease blood loss. During the procedures and management, patients were executed of continuously monitoring of arterial blood pressure, hemodynamic changes such as cardiac output, stroke volume variation, peripheral oxygen saturation, and cerebral oximeter.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80756', 'city': 'Kaohsiung City', 'state': 'Sanmin Dist', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuang-I Cheng, Phd', 'role': 'CONTACT', 'email': 'kuaich@gmail.com', 'phone': '886-7-3121101', 'phoneExt': '7035'}], 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Kuang-I Cheng, Phd', 'role': 'CONTACT', 'email': 'kuaich@gmail.com', 'phone': '886-7-3121101', 'phoneExt': '7035'}], 'overallOfficials': [{'name': 'Kuang-I Cheng, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}