Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-01 @ 9:34 AM
Study NCT ID:
NCT07481851
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Conductance for Predicting Spinal Anesthesia-Induced Hypotension in Geriatric Urologic Oncology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D014570', 'term': 'Urologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-23', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Spinal Anesthesia-Induced Hypotension', 'timeFrame': 'From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.', 'description': 'The number of participants who experience hypotension, defined as a decrease in mean arterial pressure (MAP) of ≥20% from baseline or a MAP \\<65 mmHg, within 20 minutes after spinal anesthesia.\n\nTime Frame: From initiation of spinal anesthesia until 30 minutes after spinal anesthesia.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Bradycardia After Spinal Anesthesia', 'timeFrame': 'From initiation of spinal anesthesia until 20 minutes after spinal anesthesia', 'description': 'The number of participants who experience bradycardia, defined as a heart rate of less than 50 beats/min, within 20 minutes after spinal anesthesia.'}, {'measure': 'Maximum Percentage Decrease in Mean Arterial Pressure (MAP)', 'timeFrame': 'From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.', 'description': 'The maximum percentage drop in MAP from the baseline value recorded for each participant during the observation period.'}, {'measure': 'Number of Participants Requiring Vasopressor Administration', 'timeFrame': 'From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.', 'description': 'The number of participants who require at least one dose of vasopressor (e.g., ephedrine or phenylephrine) to treat hypotension according to the study protocol.'}, {'measure': 'Changes in Skin Conductance Values', 'timeFrame': 'From baseline measurement before spinal anesthesia until 20 minutes after spinal anesthesia', 'description': 'The average change in the number of skin conductance fluctuations (peaks per second) from baseline to the point of maximum hemodynamic change.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension', 'Urologic Neoplasms', 'Aged', 'Spinal Anesthesia']}, 'referencesModule': {'references': [{'pmid': '39891061', 'type': 'BACKGROUND', 'citation': 'Norbeck DW, Lindgren S, Wolf A, Jildenstal P. Reliability of nociceptive monitors vs. standard practice during general anesthesia: a prospective observational study. BMC Anesthesiol. 2025 Jan 31;25(1):51. doi: 10.1186/s12871-025-02923-4.'}, {'pmid': '18997532', 'type': 'BACKGROUND', 'citation': 'Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.'}, {'pmid': '19025525', 'type': 'BACKGROUND', 'citation': 'Ledowski T, Preuss J, Kapila R, Ford A. Skin conductance as a means to predict hypotension following spinal anaesthesia. Acta Anaesthesiol Scand. 2008 Nov;52(10):1342-7. doi: 10.1111/j.1399-6576.2008.01697.x.'}]}, 'descriptionModule': {'briefSummary': 'Spinal anesthesia-induced hypotension is a common and clinically significant complication in elderly patients undergoing oncologic surgery. Early identification of patients at risk for hemodynamic instability remains a major challenge in perioperative management. Skin conductance reflects sympathetic nervous system activity and may provide a noninvasive indicator of autonomic responses. This prospective observational study aims to evaluate whether skin conductance measurements can predict the development of hypotension following spinal anesthesia in geriatric oncology patients undergoing urologic surgery. The findings may contribute to improved perioperative monitoring and early risk stratification in this vulnerable patient population.', 'detailedDescription': 'Spinal anesthesia is widely used in urologic oncology surgery due to its favorable analgesic profile and reduced systemic anesthetic exposure. However, spinal anesthesia frequently leads to significant hemodynamic changes, particularly hypotension, which is more pronounced in elderly patients because of age-related alterations in autonomic regulation, reduced cardiovascular reserve, and increased comorbidity burden. Spinal anesthesia-induced hypotension may result in inadequate tissue perfusion and increased perioperative morbidity, making early identification of patients at risk an important aspect of perioperative management.\n\nSkin conductance is a noninvasive physiological parameter reflecting sympathetic nervous system activity and sudomotor responses. Changes in skin conductance have been associated with variations in autonomic nervous system activity and may provide an indirect indicator of hemodynamic responses. Continuous monitoring of skin conductance may therefore offer a potential method for identifying patients who are more likely to develop hypotension after spinal anesthesia.\n\nThe aim of this prospective observational study is to investigate the relationship between skin conductance measurements and the development of hypotension following spinal anesthesia in geriatric oncology patients undergoing urologic surgery. Hemodynamic parameters including blood pressure and heart rate will be monitored perioperatively, and their association with skin conductance measurements will be evaluated. The results of this study may contribute to improving perioperative monitoring strategies and risk prediction in elderly oncology patients undergoing spinal anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of geriatric patients aged 65 years and older who are scheduled to undergo elective urologic oncology surgery under spinal anesthesia at a tertiary oncology training and research hospital. Eligible patients meeting the inclusion criteria will be prospectively enrolled. Perioperative skin conductance and hemodynamic parameters will be monitored to evaluate the association between sympathetic nervous system activity and the development of spinal anesthesia-induced hypotension.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 65 years and older\n* Patients scheduled for elective urologic oncology surgery under spinal anesthesia\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Patients who provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Refusal to participate or inability to provide informed consent\n* Contraindication to spinal anesthesia (e.g., infection at puncture site, coagulopathy)\n* Severe cardiac conduction abnormalities or presence of a cardiac pacemaker\n* Severe autonomic dysfunction or known neuropathy affecting autonomic responses\n* Use of medications that significantly affect autonomic nervous system activity\n* Baseline hypotension or hemodynamic instability before spinal anesthesia\n* Inability to obtain reliable skin conductance measurements (e.g., severe skin lesions at electrode placement site)'}, 'identificationModule': {'nctId': 'NCT07481851', 'briefTitle': 'Skin Conductance for Predicting Spinal Anesthesia-Induced Hypotension in Geriatric Urologic Oncology Patients', 'organization': {'class': 'OTHER', 'fullName': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}, 'officialTitle': 'Skin Conductance as a Predictor of Spinal Anesthesia-Induced Hypotension in Geriatric Oncology Patients', 'orgStudyIdInfo': {'id': '2025-12/205'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Geriatric Urologic Oncology Patients Undergoing Spinal Anesthesia', 'description': 'Geriatric patients undergoing urologic oncology surgery under spinal anesthesia will be prospectively observed. Skin conductance will be continuously monitored perioperatively as a noninvasive indicator of sympathetic nervous system activity. Hemodynamic parameters, including blood pressure and heart rate, will be recorded before and after spinal anesthesia. The occurrence of spinal anesthesia-induced hypotension will be assessed and its association with skin conductance measurements will be evaluated.', 'interventionNames': ['Other: Skin Conductance Monitoring']}], 'interventions': [{'name': 'Skin Conductance Monitoring', 'type': 'OTHER', 'description': 'Skin conductance will be continuously monitored using a noninvasive electrodermal activity monitoring device to assess sympathetic nervous system activity during the perioperative period. Measurements will be recorded before and after spinal anesthesia and evaluated in relation to the development of spinal anesthesia-induced hypotension.', 'armGroupLabels': ['Geriatric Urologic Oncology Patients Undergoing Spinal Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Ankara', 'state': 'Yenimahalle', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Belkis YILMAZ, Dr', 'role': 'CONTACT', 'email': 'drbelkisyilmaz@gmail.com', 'phone': '+905363275575'}], 'facility': 'Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data collected during this study will not be made publicly available. The dataset contains sensitive clinical information, and data sharing is restricted to protect participant confidentiality in accordance with institutional policies and ethical regulations. However, de-identified data may be made available from the corresponding investigator upon reasonable request and with appropriate ethical approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'tugba askin', 'investigatorAffiliation': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}}}}