Effect of Combination Dexmedetomidine Added to Fentanyl-based Intravenous Patient-controlled Analgesia on Nausea Vomiting in Highly Susceptible Patients Undergoing Lumbar Spinal Surgery: Prospective Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- total dose and bolus administration of opioid
研究概览
简要总结
The aim of this study is to test the hypothesis that addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of fentanyl bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing lumbar spine surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female, non-smoking patient who are 20-65 of age scheduled for elective lumbar spine surgery
排除标准
- •Bradycardia on EKG (45bpm)
- •Atrioventricular conduction disorder
- •Uncontrolled hypertension
- •angina history
- •obesity (BMI ≥ 30 kg/m2)
- •Preoperative administration of opioid
- •Preoperative administration of antiemetics
- •Gastrointestinal disorder history
- •Hepatic or renal disease
研究组 & 干预措施
dexmedetomidine
addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA)
干预措施: dexmedetomidine (Drug)
normal saline
normal saline as a placebo
干预措施: normal saline (Drug)
结局指标
主要结局
total dose and bolus administration of opioid
时间窗: an expected average of 48 hrs for requirements of total dose and number of bolus administration of PCA
After induction of anesthesia, peak velocity of carotid artery blood flow is measured by the pulsed wave Doppler signal obtained from the left common carotid artery. Respirophasic variation of the peak velocity is defined as the difference between the maximum and the minimum values of peak velocity divided by the mean of the two values during one respiratory cycle. Fluid responder is defined as a patient whose stroke volume index is increased ≥15% after volume expansion. The receiver operating characteristic curve analysis to discriminiate fludi responder is performed.
次要结局
- consequent postoperative nausea and vomiting(an expected average of 48 hrs for assessing of the 11-points verbal numerical rating scales)