Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Efficacy of preoperative IVC-guided fluid optimization and intravenous ondansetron in reducing the incidence of hypotension after the induction of general anesthesia
研究概览
简要总结
Hypotension is a common side-effect of general anesthesia induction and is related to adverse outcomes including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury.Half of all the patients were fluid-responsive, pointing to volume status as a significant risk factor. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration, including the maximal diameter of the IVC (dIVCmax) at the end of expiration during spontaneous respiration and the collapsibility index (CI), have been recommended as rapid and noninvasive methods for estimating volume status.
In attempt to prevent hypotension after spinal anesthesia induction, Ondansetron, a serotonin receptor antagonist, has been used effectively .
Research Question Can preoperative IVC-US guided fluid optimization and intravenous ondansetron reduce the incidence of general anesthesia-induced hypotension in adult patients undergoing elective non-cardiac non-obstetric surgery?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective, non-cardiac, non-obstetric surgery under general anesthesia
- •American Society of Anesthesiologists physical status classification I - III
排除标准
- •MAP below 60 mmhg prior to the induction of general anesthesia.
- •Patients treated with angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB) on the day of surgery.
- •Patients with heart failure with ejection fraction (EF) < 40%.
- •Patients with documented acute or chronic renal failure.
- •Patients with hepatic failure.
- •Patients with neuraxial (spinal/epidural) anesthesia performed before induction of general anesthesia.
- •Patients with suspected difficult airway.
- •Patients with documented allergy to Ondansetron or prolonged QT-syndrome.
研究组 & 干预措施
Intravenous fluid bolus
干预措施: fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone (Drug)
Intravenous Ondansetron
干预措施: fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone (Drug)
结局指标
主要结局
Efficacy of preoperative IVC-guided fluid optimization and intravenous ondansetron in reducing the incidence of hypotension after the induction of general anesthesia
时间窗: 5 years
To determine the efficacy of preoperative IVC-guided fluid optimization and intravenous ondansetron in reducing the incidence of hypotension after the induction of general anesthesia in adults presenting for elective non-cardiac, non-obstetric surgery.
次要结局
未报告次要终点