NCT04675372 - Dexmedetomidine Facilitate Analgesia | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Enrollment

181

Conditions

Lower Limb Fracture Nerve Block

Interventions

DexmedetomidineDRUG

Dexmedetomidine group (Group D) was given 1.5ug/kg/h Dexmedetomidine continuous infusion

MidazolamDRUG

Midazolam group (Group M) was continuously pumped with 0.05mg/kg/h midazolam

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

China International Neuroscience

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

nociceptive index

qNOX reached target 80 during drug infusion（qNOX\<80 Adequate；qNOX\>80 unadequate）

Time frame: During operation

Secondary Outcomes

hypoxemia

incidence of hypoxemia(SPO2\<95%Mild hypoxemia,SPO2\<90% moderate hypoxemia, SPO2\<85% severe hypoxemia)

Time frame: During operation

systolic blood pressure

Change of systolic blood pressure(SBP)

Time frame: During operation

heart rate

fluctuation of heart rate(HR)

Time frame: During operation

diastolic blood pressure

fluctuation of diastolic blood pressure(DBP)

Time frame: During operation

muscular activity

fluctuation of muscular activity (EMG)

Time frame: During operation