Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 2:25 PM
Study NCT ID:
NCT05827705
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2023-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Position and Predictive Factors of Hypotension in Prone Percutaneous Nephrolithotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D052878', 'term': 'Urolithiasis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006301', 'term': 'Health Services Needs and Demand'}, {'id': 'D004809', 'term': 'Ephedrine'}], 'ancestors': [{'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-07', 'studyFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1.Perioperatif hypotension and presence of systemic diseases', 'timeFrame': 'Perioperative period', 'description': 'Systolic blood pressure (SBP) \\<90 mmHg, mean arterial pressure (MAP) \\<65 mmHg, or a decrease of more than 20% of baseline'}, {'measure': 'Prone position effects on hypotension', 'timeFrame': 'Perioperative period', 'description': 'Systolic blood pressure (SBP) \\<90 mmHg, mean arterial pressure (MAP) \\<65 mmHg, or a decrease of more than 20% of baseline'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '30 days after the surgery', 'description': 'death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypotension', 'prone position', 'nephrolithotomy'], 'conditions': ['Hypotension', 'Urolithiasis']}, 'referencesModule': {'references': [{'pmid': '23835589', 'type': 'BACKGROUND', 'citation': 'Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.'}, {'pmid': '29661385', 'type': 'BACKGROUND', 'citation': 'Vernooij LM, van Klei WA, Machina M, Pasma W, Beattie WS, Peelen LM. Different methods of modelling intraoperative hypotension and their association with postoperative complications in patients undergoing non-cardiac surgery. Br J Anaesth. 2018 May;120(5):1080-1089. doi: 10.1016/j.bja.2018.01.033. Epub 2018 Mar 21.'}, {'pmid': '30521168', 'type': 'BACKGROUND', 'citation': 'Melo PAS, Vicentini FC, Perrella R, Murta CB, Claro JFA. Comparative study of percutaneous nephrolithotomy performed in the traditional prone position and in three different supine positions. Int Braz J Urol. 2019 Jan-Feb;45(1):108-117. doi: 10.1590/S1677-5538.IBJU.2018.0191.'}, {'pmid': '26083768', 'type': 'RESULT', 'citation': 'Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to investigate the effect of position and predictive factors on hypotension in patients performing percutaneous nephrolithotomy. Patients aged \\>18 years and ASA I-III who underwent general or regional anaesthesia were included in the study. Percutaneous access was performed in all patients with fluoroscopy in the prone position.', 'detailedDescription': 'This study was designed to investigate the effect of position and predictive factors on hypotension in patients performing percutaneous nephrolithotomy. Patients aged \\>18 years and ASA I-III who underwent general or regional anaesthesia were included in the study. Percutaneous access was performed in all patients with fluoroscopy in the prone position. Age, gender, body mass index(BMI), smoking, type of anaesthesia, duration of anaesthesia and surgery were recorded.\n\nThe ECG, SpO2, and non-invasive blood pressure values were recorded intraoperatively. Preoperative and postoperative 12th hour Hb,BUN, Cr,Na,K and Cl were measured in a blood sample. Isotonic was used as an intravenous fluid in all participants. In treatment of hypotension routine ephedrine treatments were recorded.\n\nIn the literature, studies in PCNL surgery have focused on data such as method, duration of bleeding and fluoroscopy, electrolyte-metabolic changes, and complications such as fever, hypothermia, pleural damage, and hospital stay. A limited number of studies have focused on bleeding and hemodynamics in comparing surgical methods in the prone and supine positions. the investigators could not find any study comparing systemic disease effects on intraoperative hypotension (hemodynamic parameters) in Prone PCNL surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Percutaneous access was performed in all patients with fluoroscopy in the prone position after the ureteral catheter placement in the lithotomy position as standard.', 'genderDescription': 'Patients aged \\>18 years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\>18 years and ASA I -III who underwent general or regional anaesthesia were included in the study.\n\nExclusion Criteria:\n\n* Patients who received preoperative vasopressor, inotropic infusion, erythrocyte and fresh frozen plasma (FFP), anaemia, uncontrolled coagulopathies, pregnancy, immunodeficiency, ASA class IV and emergency surgeries.'}, 'identificationModule': {'nctId': 'NCT05827705', 'briefTitle': 'Position and Predictive Factors of Hypotension in Prone Percutaneous Nephrolithotomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'The Effects of Position and Predictive Factors on Hypotension in Patients Undergoing Prone Percutaneous Nephrolithotomy', 'orgStudyIdInfo': {'id': '2011-KAEK-25 2021/03-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group H', 'description': 'General anaesthesia was induced by Propofol (2 mg/kg) IV, Rocuronium (0.6 mg/kg) and Fentanyl (2 μg/kg) IV, and maintained with sevoflurane and Epidural anesthesia, intraoperative Hypotensive patients', 'interventionNames': ['Other: need for Ephedrine hydrochloride']}, {'label': 'Group N', 'description': 'General anaesthesia was induced by Propofol (2 mg/kg) IV, Rocuronium (0.6 mg/kg) and Fentanyl (2 μg/kg) IV, and maintained with sevoflurane and Epidural anesthesia, intraoperative Non-Hypotensive patients'}], 'interventions': [{'name': 'need for Ephedrine hydrochloride', 'type': 'OTHER', 'otherNames': ['Need for ephedrine hidroclorur'], 'description': 'ephedrine dose in hypotension', 'armGroupLabels': ['Group H']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16290', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa yüksek ihtisas EAH', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Seyda E Ozgunay, 1', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bursa Yüksek İhtisas EAH'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'One year', 'ipdSharing': 'YES', 'description': 'The study protocal can be shared.', 'accessCriteria': 'Study Protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asocc Prof', 'investigatorFullName': 'Seyda Efsun Ozgunay', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}