Dexmedetomidine Facilitate Analgesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Based on the Real-time Monitoring of Nociceptive Index, Dexmedetomidine as a Neuraxial Adjuvant Facilitate Analgesia

Conditions
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Lower Limb Fracture, Nerve Block

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: incomplete effect of nerve block Alzheimer's disease implanted cardiac pacemakers mental illness epilepsy autonomic nervous system diseases projected the duration of the operation was more than 3 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Dexmedetomidine group (Group DEX) was given 1.5ug/kg/h Dexmedetomidine continuous infusion Dexmedetomidine group (Group DEX) | Drug: Dexmedetomidine<br>* Dexmedetomidine group (Group D) was given 1.5ug/kg/h Dexmedetomidine continuous infusion<br>|
| Active Comparator: Group 2<br>Midazolam group (Group MID) was continuously pumped with 0.05mg/kg/h midazolam | Drug: Midazolam<br>* Midazolam group (Group M) was continuously pumped with 0.05mg/kg/h midazolam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nociceptive index | qNOX reached target 80 during drug infusion（qNOX<80 Adequate；qNOX>80 unadequate） | During operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoxemia | incidence of hypoxemia(SPO2<95%Mild hypoxemia,SPO2<90% moderate hypoxemia, SPO2<85% severe hypoxemia) | During operation | 
| systolic blood pressure | Change of systolic blood pressure(SBP) | During operation | 
| heart rate | fluctuation of heart rate(HR) | During operation | 
| diastolic blood pressure | fluctuation of diastolic blood pressure(DBP) | During operation | 
| muscular activity | fluctuation of muscular activity (EMG) | During operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, nociceptive index