- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481851
Skin Conductance for Predicting Spinal Anesthesia-Induced Hypotension in Geriatric Urologic Oncology Patients
Skin Conductance as a Predictor of Spinal Anesthesia-Induced Hypotension in Geriatric Oncology Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Skin 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.
The 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Yenimahalle
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Ankara, Yenimahalle, Turkey (Türkiye), 06200
- Recruiting
- Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
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Contact:
- Belkis YILMAZ, Dr
- Phone Number: +905363275575
- Email: drbelkisyilmaz@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Use of medications that significantly affect autonomic nervous system activity
- Baseline hypotension or hemodynamic instability before spinal anesthesia
- Inability to obtain reliable skin conductance measurements (e.g., severe skin lesions at electrode placement site)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Geriatric Urologic Oncology Patients Undergoing Spinal Anesthesia
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants with Spinal Anesthesia-Induced Hypotension
Time Frame: From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.
|
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. |
From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Bradycardia After Spinal Anesthesia
Time Frame: From initiation of spinal anesthesia until 20 minutes 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.
|
From initiation of spinal anesthesia until 20 minutes after spinal anesthesia
|
|
Maximum Percentage Decrease in Mean Arterial Pressure (MAP)
Time Frame: From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.
|
The maximum percentage drop in MAP from the baseline value recorded for each participant during the observation period.
|
From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.
|
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Number of Participants Requiring Vasopressor Administration
Time Frame: From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.
|
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.
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From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.
|
|
Changes in Skin Conductance Values
Time Frame: From baseline measurement before spinal anesthesia until 20 minutes after spinal anesthesia
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The average change in the number of skin conductance fluctuations (peaks per second) from baseline to the point of maximum hemodynamic change.
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From baseline measurement before spinal anesthesia until 20 minutes after spinal anesthesia
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-12/205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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