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临床试验/NCT06563297
NCT06563297尚未招募4 期

To Explore the Optimal Dose of Alfentanil for Skull Pin Fixation Under Surgical Pleth Index Monitor in Intracranial Surgery

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月13日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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