To Explore the Optimal Dose of Alfentanil for Skull Pin Fixation Under Surgical Pleth Index Monitor in Intracranial Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 95% effect concentration of alfentanil
研究概览
简要总结
Forty patients were enrolled, and all patients used total intravenous anesthesia (alfentanil-propofol based TIVA) as anesthesia induction and maintenance. According to our experience, patients who underwent intracranial surgery for skull pin fixation used alfentanil 100 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by EEG, maintaining a value of 40-60), first start with alfentanil 100 ng/ml, and use the up and down method as adjust 25 ng/ml of concentration of alfentanil each time. An SPI higher than 80 and hyperdynamics (the increased HR and MBP up 20% of baseline or HR>100bpm and ABP>180/100mmHg) indicates insufficient analgesia, therefore increase it by 25 ng/ml at the next patient; an SPI lower than 80 and stable hemodynamics (the changes of HR and MBP within 20% of baseline or HR<50bpm and ABP<90/50mmHg) indicates that analgesia is acceptable, and the next patient will decrease it by 25 ng/ml during skull pin fixation. If the analgesia is inadequate, increase alfentanil concentration will be prescribed. On the other hand, if analgesia is adequate, however hyperdynamics was noted, beta blocker or calcium channel blocker will be prescribed. If hypotension (ABP<90/50 mmHg) or bradycardia (HR<50 bpm) occur, we first stop alfentanil infusion and treated with ephedrine or atropine, respectively.
Data collection: HR, MBP, SPI, BIS, systolic pressure variation (SPV), pulse pressure variation (PPV) , concentrations of propofol and alfentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years old and less than 80 years old
- •With anesthesia risk grade below grade three (including grade three) (ASA I~III)
- •Patients who are expected to undergo intracranial surgery for skull pin fixation
排除标准
- •Those with anesthesia risk classification ASA class IV or higher
- •Those who are allergic to alfentanil or propofol drugs
- •Emergency patients
研究组 & 干预措施
Participant Group
Neurosurgery with fixation
干预措施: Alfentanil (Drug)
结局指标
主要结局
95% effect concentration of alfentanil
时间窗: peri-fixation period
95% effect concentration of alfentanil will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
50% effect concentration of alfentanil
时间窗: peri-fixation period
50% effect concentration of alfentanil will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
次要结局
未报告次要终点
