Based on the Real-time Monitoring of Nociceptive Index, Dexmedetomidine as a Neuraxial Adjuvant Facilitate Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- nociceptive index
研究概览
简要总结
Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.
详细描述
Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive substances and further interrupting the spinal neuron-glia cross talk and regulating the nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy of Dexmedetomidine compared with Midazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged from 18 to 80 years old
- •American Association of anesthesiologists (ASA) grade Ⅱ ~ IV
- •body mass index (BMI) 18.5-40
- •planning undergoing peripheral nerve block
排除标准
- •incomplete effect of nerve block
- •Alzheimer's disease
- •implanted cardiac pacemakers
- •mental illness
- •autonomic nervous system diseases
- •projected the duration of the operation was more than 3 hours
研究组 & 干预措施
Group 1
Dexmedetomidine group (Group DEX) was given 1.5ug/kg/h Dexmedetomidine continuous infusion Dexmedetomidine group (Group DEX)
干预措施: Dexmedetomidine (Drug)
Group 2
Midazolam group (Group MID) was continuously pumped with 0.05mg/kg/h midazolam
干预措施: Midazolam (Drug)
结局指标
主要结局
nociceptive index
时间窗: During operation
qNOX reached target 80 during drug infusion（qNOX\<80 Adequate；qNOX\>80 unadequate）
次要结局
- heart rate(During operation)
- hypoxemia(During operation)
- systolic blood pressure(During operation)
- diastolic blood pressure(During operation)
- muscular activity(During operation)