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

NCT07551219 | Completed

• 1 other identifier: TABED1-24-840
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence of Spinal Anesthesia-Induced Hypotension

  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.

  rom induction of spinal anesthesia until the end of surgery

• Incidence of Spinal Anesthesia-Induced Bradycardia

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

  From induction of spinal anesthesia until the end of surgery

Secondary Outcomes (2)

• Ephedrine Requirement

  From induction of spinal anesthesia until the end of surgery

• Atropine Requirement

  From induction of spinal anesthesia until the end of surgery

Study Arms (2)

Ondansetron Group

Geriatric patients undergoing urologic surgery under spinal anesthesia who received intravenous ondansetron as part of routine clinical practice prior to spinal block. Patients were observed without investigator-directed intervention.

Control Group

Geriatric patients undergoing urologic surgery under spinal anesthesia who did not receive ondansetron prior to spinal block and were managed according to routine clinical practice.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of geriatric patients aged 65 years and older undergoing elective urologic surgery under spinal anesthesia. Patients were managed according to routine clinical practice, with or without prophylactic ondansetron administration. Perioperative hemodynamic parameters, including blood pressure and heart rate, were prospectively recorded during the intraoperative period.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension; Bradycardia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeynep Nur Akçaboy, MD

  Department of Anesthesiology, Ankara City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 24, 2026
• Study Start: December 18, 2024
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)