Lower Limb Fracture, Nerve Block
Conditions
Keywords
Dexmedetomidine, nociceptive index
Brief summary
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
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine group (Group D) was given 1.5ug/kg/h Dexmedetomidine continuous infusion
DRUGMidazolam
Midazolam group (Group M) was continuously pumped with 0.05mg/kg/h midazolam
Sponsors
China International Neuroscience Institution
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| nociceptive index | During operation | qNOX reached target 80 during drug infusion（qNOX\<80 Adequate；qNOX\>80 unadequate） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hypoxemia | During operation | incidence of hypoxemia(SPO2\<95%Mild hypoxemia,SPO2\<90% moderate hypoxemia, SPO2\<85% severe hypoxemia) |
| systolic blood pressure | During operation | Change of systolic blood pressure(SBP) |
| heart rate | During operation | fluctuation of heart rate(HR) |
| diastolic blood pressure | During operation | fluctuation of diastolic blood pressure(DBP) |
| muscular activity | During operation | fluctuation of muscular activity (EMG) |
Countries
China
Outcome results
None listed