Effects of Ondansetron on Hemodynamic Changes Induced by Spinal Anesthesia in Geriatric Urologic Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence of Spinal Anesthesia-Induced Hypotension
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Incidence of Spinal Anesthesia-Induced Hypotension
时间窗: 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.
Incidence of Spinal Anesthesia-Induced Bradycardia
时间窗: 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.
次要结局
- Ephedrine Requirement(From induction of spinal anesthesia until the end of surgery)
- Atropine Requirement(From induction of spinal anesthesia until the end of surgery)
研究者
Kübra Deniz
Anesthesiology Resident
Ankara City Hospital Bilkent