The Correlation of Narcotrend Index and OAA/S Scale in Monitoring Sedation Level With Different Doses of Dexmedetomidine
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the correlation coefficient between OAA/S scale and Narcotrend index in group 1
研究概览
简要总结
Narcotrend index is a widely used quantitative parameter for evaluating anesthesia and sedation levels.Dexmedetomidine is a novel sedative,providing sedation while patients remain cooperative and can be easily aroused. This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of dexmedetomidine intravenously.
详细描述
60 patients,aged 20～60,American Society of Anesthesiologists (ASA) physical status ⅠorⅡ, scheduled for electively lower limb surgery undergoing combined spinal epidural anesthesia were randomly divided three group. In each group,a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia. The initial dose in group 1, group 2 and group 3 was started from 0.9 µg/kg,1.0 µg/kg and 1.1 µg/kg, respectively. HR、MAP、SpO2、the Observer's Assessment of Alertness/Sedation（OAA/S）scale and the corresponding Narcotrend index were recorded at 5-minute intervals until 30 minutes after administration. The relationship between OAA/S scale and Narcotrend index was analyzed by a Spearman analysis. The cutoff values of Narcotrend index for OAA/S≤2 were obtained by analysis of receiver operating characteristic curves(ROC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Ⅰ ~ Ⅱ women undergoing Laparoscopic surgery.
- •Written informed consent from the patient or the relatives of the participating patient.
- •BMI:18.0～25 kg/m2
排除标准
- •Mental illness can not match
- •epidural anesthesia contraindicated
- •People who have Slow-type arrhythmias
- •Chronic renal failure
- •Alcohol or drug abuse
- •Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
研究组 & 干预措施
group 1
patients in group 1, aged 20~60, were accepted an initial dose of 0.9μg/kg dexmedetomidine over 15 min.
干预措施: Dexmedetomidine (Drug)
group 2
patients in group 2, aged 20~60, were accepted an initial dose of 1.0μg/kg dexmedetomidine over 15 min.
干预措施: Dexmedetomidine (Drug)
group 3
patients in group 3, aged 20~60, were accepted an initial dose of 1.1μg/kg dexmedetomidine over 15 min.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
the correlation coefficient between OAA/S scale and Narcotrend index in group 1
时间窗: at 5-minute intervals until 30 minutes after administration
This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 0.9 μg/kg dexmedetomidine intravenously.
the correlation coefficient between OAA/S scale and Narcotrend index in group 2
时间窗: at 5-minute intervals until 30 minutes after administration
This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 1.0 μg/kg dexmedetomidine intravenously.
the correlation coefficient between OAA/S scale and Narcotrend index in group 3
时间窗: at 5-minute intervals until 30 minutes after administration
This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 1.1 μg/kg dexmedetomidine intravenously.
次要结局
- The calculated cutoff values for OAA/S≤ 2(at 5-minute intervals until 30 minutes after administration)
研究者
bo xu
associate chief physician
Guangzhou General Hospital of Guangzhou Military Command