Dexmedetomidine Facilitate Analgesia | NCT04675372

Studies
Dexmedetomidine Facilitate Analgesia

NCT04675372

Sponsor

China International Neuroscience Institution

Status

Completed

Last Update Posted

Aug 5, 2021Actual

Enrollment

181Actual

Phase

Phase 4

Conditions

Lower Limb Fracture
Nerve Block

Interventions

Dexmedetomidine
Midazolam

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2021Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Aug 3, 2021Actual

First Submitted Date

Dec 11, 2020

First Submission Date that Met QC Criteria

Dec 17, 2020

First Posted Date

Dec 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2021

Last Update Posted Date

Aug 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

181Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	Dexmedetomidine group (Group D) was given 1.5ug/kg/h Dexmedetomidine continuous infusion	Group 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China International Neuroscience		Beijing	Beijing Municipality	100053	China

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D008874	Midazolam

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided