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Dexmedetomidine Facilitate Analgesia

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ClinicalTrials.gov Identifier: NCT04675372
Recruitment Status : Completed
First Posted : December 19, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
China International Neuroscience Institution

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lower Limb Fracture Nerve Block Drug: Dexmedetomidine Drug: Midazolam Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Based on the Real-time Monitoring of Nociceptive Index, Dexmedetomidine as a Neuraxial Adjuvant Facilitate Analgesia
Actual Study Start Date : January 19, 2021
Actual Primary Completion Date : August 1, 2021
Actual Study Completion Date : August 3, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Dexmedetomidine group (Group DEX) was given 1.5ug/kg/h Dexmedetomidine continuous infusion Dexmedetomidine group (Group DEX)
 Drug: Dexmedetomidine
Dexmedetomidine group (Group D) was given 1.5ug/kg/h Dexmedetomidine continuous infusion
Active Comparator: Group 2
Midazolam group (Group MID) was continuously pumped with 0.05mg/kg/h midazolam
 Drug: Midazolam
Midazolam group (Group M) was continuously pumped with 0.05mg/kg/h midazolam


Outcome Measures
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Primary Outcome Measures :
  1. nociceptive index [ Time Frame: During operation ]
    qNOX reached target 80 during drug infusion（qNOX<80 Adequate；qNOX>80 unadequate）


Secondary Outcome Measures :
  1. hypoxemia [ Time Frame: During operation ]
    incidence of hypoxemia(SPO2<95%Mild hypoxemia,SPO2<90% moderate hypoxemia, SPO2<85% severe hypoxemia)

  2. systolic blood pressure [ Time Frame: During operation ]
    Change of systolic blood pressure(SBP)

  3. heart rate [ Time Frame: During operation ]
    fluctuation of heart rate(HR)

  4. diastolic blood pressure [ Time Frame: During operation ]
    fluctuation of diastolic blood pressure(DBP)

  5. muscular activity [ Time Frame: During operation ]
    fluctuation of muscular activity (EMG)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675372


Locations
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China, Beijing
China International Neuroscience
Beijing, Beijing, China, 100053
Sponsors and Collaborators
China International Neuroscience Institution
More Information
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Responsible Party: China International Neuroscience Institution
ClinicalTrials.gov Identifier: NCT04675372    
Other Study ID Numbers: IRB-XWAD-202008-12
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China International Neuroscience Institution:
Dexmedetomidine
nociceptive index
Additional relevant MeSH terms:
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Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents