Dexmedetomidine Facilitate Analgesia

Phase 4

Completed

• Conditions: Lower Limb Fracture; Nerve Block
• Interventions: Drug: Midazolam; Drug: Dexmedetomidine

• Registration Number: NCT04675372
• Lead Sponsor: China International Neuroscience Institution

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.

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-19
• Study Start: 2021-01-19
• Status Verified: 2021-08
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-03
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Midazolam	Midazolam group (Group MID) was continuously pumped with 0.05mg/kg/h midazolam
Group 1	Dexmedetomidine	Dexmedetomidine group (Group DEX) was given 1.5ug/kg/h Dexmedetomidine continuous infusion Dexmedetomidine group (Group DEX)

Primary Outcome Measures

Name	Time	Method
nociceptive index	During operation	qNOX reached target 80 during drug infusion（qNOX\<80 Adequate；qNOX\>80 unadequate）

Secondary Outcome Measures

Name	Time	Method
heart rate	During operation	fluctuation of heart rate(HR)
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)
diastolic blood pressure	During operation	fluctuation of diastolic blood pressure(DBP)
muscular activity	During operation	fluctuation of muscular activity (EMG)

Trial Locations

Locations (1)

China International Neuroscience; 🇨🇳 Beijing, Beijing, China