HypotensionNCT07481851
Skin Conductance for Predicting Spinal Anesthesia-Induced Hypotension in Geriatric Urologic Oncology Patients
An observational study of Hypotension and Urologic Neoplasms, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypotension, Urologic Neoplasms, Aged
- What is being tested?
- Skin Conductance Monitoring
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
Ankara, Yenimahalle, 06200
Belkis YILMAZ, Dr, +905363275575, drbelkisyilmaz@gmail.com
About this study
Official title: Skin Conductance as a Predictor of Spinal Anesthesia-Induced Hypotension in Geriatric Oncology Patients
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.
Read the 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.
- Conditions
- Hypotension, Urologic Neoplasms, Aged, Spinal Anesthesia
- Being tested
- Skin Conductance Monitoring
- Medical subject headings
- Hypotension, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Conductance MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Skin Conductance Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.
Secondary outcomes (4)
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.
Measured: From initiation of spinal anesthesia until 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.
Measured: From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.
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.
Measured: From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.
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.
Measured: From baseline measurement before spinal anesthesia until 20 minutes after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start22 Dec 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tugba askin, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481851
- Sponsor's protocol ID
- 2025-12/205
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39891061Storm 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.
PubMed 18997532Ledowski 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.
PubMed 19025525
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Conductance as a Predictor of Spinal Anesthesia-Induced Hypotension in Geriatric Oncology Patients
- ClinicalTrials.gov ID
- NCT07481851
- Acronym / sponsor ID
- 2025-12/205
- Conditions
- Hypotension, Urologic Neoplasms, Aged, Spinal Anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Urologic Oncology Patients Undergoing Spinal Anesthesia | – | Other: Skin Conductance MonitoringGeriatric 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Conductance MonitoringSkin 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. | Other | Geriatric Urologic Oncology Patients Undergoing Spinal Anesthesia |
Primary outcome
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.
4 secondary outcomes
Incidence of Bradycardia After Spinal Anesthesia
Time frame: 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.
Number of Participants Requiring Vasopressor Administration
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 39891061Norbeck 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.
- Background: PubMed 18997532Storm 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.
- Background: PubMed 19025525Ledowski 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
Ankara, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Urologic Neoplasms, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Spinal Anesthesia-Induced Hypotension (time frame: From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07481851, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.