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Dexmedetomidine Facilitate Analgesia

Sponsor
China International Neuroscience Institution (Other)
Overall Status
Completed
CT.gov ID
NCT04675372
Collaborator
(none)
181
Enrollment
1
Location
2
Arms
6.4
Actual Duration (Months)
28.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Jan 19, 2021
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Aug 3, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. nociceptive index [During operation]

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

Secondary Outcome Measures

  1. hypoxemia [During operation]

    incidence of hypoxemia(SPO2<95%Mild hypoxemia,SPO2<90% moderate hypoxemia, SPO2<85% severe hypoxemia)

  2. systolic blood pressure [During operation]

    Change of systolic blood pressure(SBP)

  3. heart rate [During operation]

    fluctuation of heart rate(HR)

  4. diastolic blood pressure [During operation]

    fluctuation of diastolic blood pressure(DBP)

  5. muscular activity [During operation]

    fluctuation of muscular activity (EMG)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 China International Neuroscience Beijing Beijing China 100053

Sponsors and Collaborators

  • China International Neuroscience Institution

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
China International Neuroscience Institution
ClinicalTrials.gov Identifier:
NCT04675372
Other Study ID Numbers:
  • IRB-XWAD-202008-12
First Posted:
Dec 19, 2020
Last Update Posted:
Aug 5, 2021
Last Verified:
Aug 1, 2021
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:
Midazolam
Dexmedetomidine

Study Results

No Results Posted as of Aug 5, 2021