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临床试验/NCT05125328
NCT05125328已完成4 期

To Explore the Optimal Dose of Remifentanil for Skull Pin Fixation 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 27 人开始时间: 2023年4月19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
已完成
入组人数
27
试验地点
1
主要终点
50% effect concentration of remifentanil

研究概览

简要总结

Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 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 electroencephalography, maintaining a value of 40-60), first start with remifentanil 6.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. An Analgesia Nociception Index(ANI) lower than 30 and hyperdynamics (the increased heart rate(HR) and mean blood pressure(MBP) up 20% of baseline or HR>100bpm and arterial blood pressure(ABP)>180/100mmHg) indicates insufficient analgesia, therefore increase it by 0.5 ng/ml; an ANI higher than 30 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 0.5 ng/ml during skull pin fixation.

Data collection: Heart Rate, Measure blood pressure, Analgesia Nociception Index, Bispectral index, concentrations of propofol and remifentanil 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
20 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 20 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 opioid analgesics or propofol drugs
  • Emergency patients

研究组 & 干预措施

neurosurgery with fixation

Experimental

干预措施: Remifentanil (Drug)

结局指标

主要结局

50% effect concentration of remifentanil

时间窗: peri-fixation period

50% effect concentration of remifentanil will be recorded at 2 mins before fixation, during fixation, 5mins after fixation, and 15 mins after fixation.

90% effect concentration of remifentanil

时间窗: peri-fixation period

90% effect concentration of remifentanil will be recorded at 2 mins before fixation, during fixation, 5mins 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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ANI and Remifentanil in Skull Pin Fixation. | 临床试验