Dexmedetomidine Facilitate Analgesia

NCT ID: NCT04675372

Last Updated: 2021-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-19

Study Completion Date

2021-08-03

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.

Conditions

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Lower Limb Fracture Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Group 2

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Midazolam

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China International Neuroscience Institution

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China International Neuroscience

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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IRB-XWAD-202008-12

Identifier Type: -

Identifier Source: org_study_id

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