Effect of Remifentanil Administration on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Arterial Blood Pressure After Head Fixation
研究概览
简要总结
To identify a better method using a combination of routine anesthetic drugs to improve hemodynamic stability during Mayfield head pinning for craniotomy surgery.
详细描述
A randomized, placebo-controlled, double-blinded comparative effectiveness study to test hypothesis that addition of remifentanil bolus to a standard anesthetic drug regimen will better attenuate the hemodynamic response to the noxious stimulus of Mayfield head pin insertion than the standard anesthetic drug regimen.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult non-pregnant patients
- •undergoing general anesthesia for a craniotomy
- •requiring a Mayfield head fixation device.
排除标准
- •Patients under 18 years of age,
- •non-English speaking,
- •pregnancy,
- •opioid tolerance,
- •illegal drug use or alcohol abuse.
研究组 & 干预措施
Remifentanil
Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
干预措施: Remifentanil (Drug)
Normal Saline
Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
干预措施: Normal Saline (Drug)
结局指标
主要结局
Mean Arterial Blood Pressure After Head Fixation
时间窗: Ten minute window after head fixation
次要结局
- Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations(10 minute window after head fixation)
研究者
Laura Hemmer
Assistant Professor of Anesthesiology and Neurological Surgery
Northwestern University