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NCT Number: NCT07551219

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

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.

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Key information

Conditions

Hypotension Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Hypotension During Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Anesthesia Induced Hemodynamic Change Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Spinal Anesthesia-Induced Hypotension

    Time frame: rom induction of spinal anesthesia until the end of surgery

    The occurrence of spinal anesthesia-induced hypotension, defined as a decrease in mean arterial pressure of 20% or more from baseline during the intraoperative period.

  2. Incidence of Spinal Anesthesia-Induced Bradycardia

    Time frame: From induction of spinal anesthesia until the end of surgery

    The occurrence of spinal anesthesia-induced bradycardia, defined as a decrease in heart rate of 20% or more from baseline during the intraoperative period.

Secondary outcomes

  1. Ephedrine Requirement

    Time frame: From induction of spinal anesthesia until the end of surgery

    The need for intraoperative ephedrine administration to treat hypotension following spinal anesthesia.

  2. Atropine Requirement

    Time frame: From induction of spinal anesthesia until the end of surgery

    The need for intraoperative atropine administration to treat bradycardia following spinal anesthesia.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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