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Effects of Ondansetron on Hemodynamic Changes After Spinal Anesthesia in Geriatric Urologic Surgery

Effects of Ondansetron on Hemodynamic Changes Induced by Spinal Anesthesia in Geriatric Urologic Surgery Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07551219
Enrollment
140
Registered
2026-04-24
Start date
2024-12-18
Completion date
2025-04-18
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia, Hypotension, Hypotension During Surgery, Spinal Anesthesia Induced Hemodynamic Change

Keywords

ondansetron, spinal anesthesia, geriatric patients, hemodynamic instability, urologic surgery

Brief summary

Spinal anesthesia is frequently used in urologic surgery in geriatric patients; however, it may cause significant hemodynamic changes such as hypotension and bradycardia. These changes can be more pronounced in elderly patients due to age-related physiological alterations. Ondansetron, a 5-HT3 receptor antagonist commonly used for the prevention of postoperative nausea and vomiting, has been suggested to attenuate spinal anesthesia-induced hemodynamic instability by modulating vagal reflexes. This prospective observational study aimed to evaluate the effects of ondansetron on hemodynamic changes following spinal anesthesia in geriatric patients undergoing urologic surgery. Hemodynamic parameters were recorded during the intraoperative period, and the incidence of hypotension, bradycardia, and vasopressor requirements were assessed.

Detailed description

This study was designed as a prospective observational study conducted in geriatric patients undergoing urologic surgery under spinal anesthesia. Patient enrollment and data collection were performed prospectively between December 18, 2024, and April 18, 2025. The study protocol was approved by the TABED Ethics Committee (Approval No: 1-24-840, December 18, 2024). Ondansetron was administered according to routine clinical practice. Hemodynamic parameters, including mean arterial pressure and heart rate, were recorded at predefined time points following spinal anesthesia. The incidence of spinal anesthesia-induced hypotension, bradycardia, and the need for vasopressor support were evaluated. Although patient enrollment and data collection were conducted prospectively, the study was registered retrospectively at ClinicalTrials.gov due to delayed trial registration.

Interventions

None listed

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged 65 years and older Patients scheduled for elective urologic surgery under spinal anesthesia American Society of Anesthesiologists (ASA) physical status I-III Patients who received routine perioperative management, with or without ondansetron administration Patients who provided written informed consent

Exclusion criteria

* Refusal or contraindication to spinal anesthesia Known hypersensitivity or contraindication to ondansetron Preexisting severe cardiac conduction abnormalities (e.g., high-grade atrioventricular block, sick sinus syndrome) Baseline bradycardia (heart rate \< 50 beats per minute) Chronic use of medications significantly affecting heart rate or blood pressure (e.g., beta-blockers, calcium channel blockers, antiarrhythmic drugs) Emergency surgery Incomplete perioperative hemodynamic data

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Spinal Anesthesia-Induced Hypotensionrom induction of spinal anesthesia until the end of surgeryThe occurrence of spinal anesthesia-induced hypotension, defined as a decrease in mean arterial pressure of 20% or more from baseline during the intraoperative period.
Incidence of Spinal Anesthesia-Induced BradycardiaFrom induction of spinal anesthesia until the end of surgeryThe occurrence of spinal anesthesia-induced bradycardia, defined as a decrease in heart rate of 20% or more from baseline during the intraoperative period.

Secondary

MeasureTime frameDescription
Ephedrine RequirementFrom induction of spinal anesthesia until the end of surgeryThe need for intraoperative ephedrine administration to treat hypotension following spinal anesthesia.
Atropine RequirementFrom induction of spinal anesthesia until the end of surgeryThe need for intraoperative atropine administration to treat bradycardia following spinal anesthesia.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORZeynep Nur Akçaboy, MD

Department of Anesthesiology, Ankara City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026