Effect pf Preemptive Low Dose Norepinephrine Infusion on Hemodynamic Stability in Brain Tumor Resection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The number of patients with hemodynamic unstability
研究概览
简要总结
In the experimental group, norepinephrine at a concentration of 5 mcg/ml is preemptively administered through peripheral venous catheter with a size of 20 G or more from the time of anesthesia induction to the end of anesthetic administration. The norepinephrine is not preemptively administered in the control group. For anesthesia, total intravenous anesthesia using propofol and remifentanil is performed. During anesthesia, the injection rate of the test drug is allowed to be adjusted according to the blood pressure within the permissible range, and anesthesia management such as fluid infusion, blood transfusions, and drug administration is performed according to the judgment of the anesthesiologist, and there are no restrictions.
The achievement of hemodynamic stability during anesthesia is judged by the percentage (%) of the time when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure during the total anesthesia duration. The number of hemodynamic unstability occurred, and the number of patients with hemodynamic unstability are also sought. The incidence of postoperative complications between the two groups is also compared.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 to 65 who undergo elective craniotomy for brain tumor resection
排除标准
- •emergency surgery
- •If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.)
- •cognitive dysfunction
- •pregnant, lactating
- •Congestive heart failure (New York Heart Association scores ≥3)
- •Renal dysfunction (estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2)
- •Patients with severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, asthma under treatment, etc.)
- •Uncontrolled hypertension (baseline blood pressure greater than 140/90)
研究组 & 干预措施
experimental group
norepinephrine at a concentration of 5 mcg/ml is preemptively administered
干预措施: norepinephrine (Drug)
结局指标
主要结局
The number of patients with hemodynamic unstability
时间窗: during the total anesthesia duration (maximum up to 24 hours)
※ hemodynamic unstability is defined when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure
the percentage (%) of the time when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure during the total anesthesia duration
时间窗: during the total anesthesia duration (maximum up to 24 hours)
The number of hemodynamic unstability occurred
时间窗: during the total anesthesia duration (maximum up to 24 hours)
※ hemodynamic unstability is defined when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure
次要结局
未报告次要终点