Dexmedetomidine Facilitate Analgesia

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

Study Overview

• Status: Completed
• Conditions: Nerve Block; Lower Limb Fracture
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: 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 Type: Interventional
• Enrollment (Actual): 181
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • China International Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nociceptive index	qNOX reached target 80 during drug infusion（qNOX<80 Adequate；qNOX>80 unadequate）	During operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypoxemia	incidence of hypoxemia(SPO2<95%Mild hypoxemia,SPO2<90% moderate hypoxemia, SPO2<85% severe hypoxemia)	During operation
systolic blood pressure	Change of systolic blood pressure(SBP)	During operation
heart rate	fluctuation of heart rate(HR)	During operation
diastolic blood pressure	fluctuation of diastolic blood pressure(DBP)	During operation
muscular activity	fluctuation of muscular activity (EMG)	During operation

Collaborators and Investigators

• Sponsor: China International Neuroscience Institution

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 3, 2021

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Dexmedetomidine; nociceptive index
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: IRB-XWAD-202008-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No