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
systolic blood pressure	During operation	Change of systolic blood pressure(SBP)
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)
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