About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 65 years and older
Patients scheduled for elective urologic oncology surgery under spinal anesthesia
American Society of Anesthesiologists (ASA) physical status I-III
Patients who provide written informed consent to participate in the study
Disqualifiers
Refusal to participate or inability to provide informed consent
Contraindication to spinal anesthesia (e.g., infection at puncture site, coagulopathy)
Severe cardiac conduction abnormalities or presence of a cardiac pacemaker
Severe autonomic dysfunction or known neuropathy affecting autonomic responses
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Skin Conductance Monitoring
Other interventionSkin 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.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with Spinal Anesthesia-Induced Hypotension
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. Time Frame: From initiation of spinal anesthesia until 30 minutes after spinal anesthesia.
Secondary outcomes
Incidence of Bradycardia After Spinal Anesthesia
The number of participants who experience bradycardia, defined as a heart rate of less than 50 beats/min, within 20 minutes after spinal anesthesia.
Maximum Percentage Decrease in Mean Arterial Pressure (MAP)
The maximum percentage drop in MAP from the baseline value recorded for each participant during the observation period.
Number of Participants Requiring Vasopressor Administration
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.
Changes in Skin Conductance Values
The average change in the number of skin conductance fluctuations (peaks per second) from baseline to the point of maximum hemodynamic change.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.