Dexmedetomidine Facilitate Analgesia

NCT04675372 | Completed Phase 4 DMC

• 1 other identifier: IRB-XWAD-202008-12
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Fracture; Nerve Block

Keywords

Dexmedetomidine; nociceptive index

Outcome Measures

Primary Outcomes (1)

• nociceptive index

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

  During operation

Secondary Outcomes (5)

• hypoxemia

  During operation

• systolic blood pressure

  During operation

• heart rate

  During operation

• diastolic blood pressure

  During operation

• muscular activity

  During operation

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Dexmedetomidine

Group 2

ACTIVE COMPARATOR

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

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

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

Group 1

Midazolam DRUG

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

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China International Neuroscience Institution: lead

Study Sites (1)

China International Neuroscience

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 19, 2020
• Study Start: January 19, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 3, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-08

Locations

CN (1)