Dexmedetomidine Facilitate Analgesia

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04675372
• Other study ID #: IRB-XWAD-202008-12
• Status: Completed
• Phase: Phase 4
• Start date: January 19, 2021
• Est. completion date: August 3, 2021

Study information

• Verified date: August 2021
• Source: China International Neuroscience Institution
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: August 3, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• aged from 18 to 80 years old
• American Association of anesthesiologists (ASA) grade ? ~ 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

Related Conditions & MeSH terms

• Lower Limb Fracture
• Nerve Block

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine group (Group D) was given 1.5ug/kg/h Dexmedetomidine continuous infusion
• Midazolam
Midazolam group (Group M) was continuously pumped with 0.05mg/kg/h midazolam

Locations

Country	Name	City	State
China	China International Neuroscience	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China International Neuroscience Institution

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nociceptive index	qNOX reached target 80 during drug infusion(qNOX<80 Adequate;qNOX>80 unadequate)	During operation
Secondary	hypoxemia	incidence of hypoxemia(SPO2<95%Mild hypoxemia,SPO2<90% moderate hypoxemia, SPO2<85% severe hypoxemia)	During operation
Secondary	systolic blood pressure	Change of systolic blood pressure(SBP)	During operation
Secondary	heart rate	fluctuation of heart rate(HR)	During operation
Secondary	diastolic blood pressure	fluctuation of diastolic blood pressure(DBP)	During operation
Secondary	muscular activity	fluctuation of muscular activity (EMG)	During operation