NCT07481851

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 16, 2026

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.

Secondary Outcomes (4)

  • Incidence of Bradycardia After Spinal Anesthesia

    From initiation of spinal anesthesia until 20 minutes after spinal anesthesia

  • Maximum Percentage Decrease in Mean Arterial Pressure (MAP)

    From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.

  • Number of Participants Requiring Vasopressor Administration

    From initiation of spinal anesthesia until 20 minutes after spinal anesthesia.

  • Changes in Skin Conductance Values

    From baseline measurement before spinal anesthesia until 20 minutes after spinal anesthesia

Study Arms (1)

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.

Other: Skin Conductance Monitoring

Interventions

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.

Geriatric Urologic Oncology Patients Undergoing Spinal Anesthesia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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: 39891061BACKGROUND
  • 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: 18997532BACKGROUND
  • 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.

    PMID: 19025525BACKGROUND

MeSH Terms

Conditions

HypotensionUrologic Neoplasms

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 19, 2026

Study Start

December 22, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations