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NCT Number: NCT04675372

Dexmedetomidine Facilitate Analgesia

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.

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Key information

Conditions

Lower Limb Fracture Nerve Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

China International Neuroscience

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

midazolam

Drug

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

Primary outcomes

  1. nociceptive index

    Time frame: During operation

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

China International Neuroscience Institution

Other

Registry information

Official study title

Based on the Real-time Monitoring of Nociceptive Index, Dexmedetomidine as a Neuraxial Adjuvant Facilitate Analgesia

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2020
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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