Assessing the Time-Course of Dexmedetomidine-Induced Anal... | NCT06946277

Studies
Assessing the Time-Course of Dexmedetomidine-Induced Analgesia Via EEG

NCT06946277

Sponsor

China International Neuroscience Institution

Status

Not yet recruiting

Last Update Posted

Apr 27, 2025Actual

Enrollment

20Estimated

Phase

Phase 4

Conditions

Total Hip Arthroplasty (THA)
Intrathecal Anesthesia
Hip Osteoarthritis

Interventions

Preemptive Analgesia Of Dexmedetomidine

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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2025Estimated

Primary Completion Date

May 25, 2025Estimated

Completion Date

May 26, 2025Estimated

First Submitted Date

Apr 11, 2025

First Submission Date that Met QC Criteria

Apr 23, 2025

First Posted Date

Apr 27, 2025Actual

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

Apr 23, 2025

Last Update Posted Date

Apr 27, 2025Actual

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

Objective: To investigate the temporal dynamics of dexmedetomidine's analgesic effects in the brain using EEG.

Methods: Eligible patients scheduled for total hip arthroplasty under intrathecal anesthesia received a continuous infusion of DEX at 1.5 μg/(kg·h) for 15 minutes before neuraxial puncture, followed by an additional 15-minute infusion. The study was divided into three phases:

Phase 1: Non-dosing phase (Baseline). Phase 2: DEX preemptive analgesia phase (DEX infusion). Phase 3: DEX cessation phase (Post-infusion).

Outcomes:

Primary safety outcome: EEG spectral analysis at different phases. Secondary outcomes: NRS scores, postoperative nausea and vomiting (PONV), dizziness, agitation, and time to intestinal exhaust within 48 hours. Intraoperative hemodynamics were also monitored.

Detailed Description

Objective: To investigate the temporal dynamics of dexmedetomidine's analgesic effects in the brain using EEG.

Phase 1: Non-dosing phase (Baseline). Phase 2: DEX preemptive analgesia phase (DEX infusion). Phase 3: DEX cessation phase (Post-infusion).

Outcomes:

EEG/ERP monitoring: The 64-site EEG and ERP were recorded at different phases

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexmedetomidine Preemptive Analgesia	Experimental		Drug: Preemptive Analgesia Of Dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preemptive Analgesia Of Dexmedetomidine	Drug	Preemptive Analgesia Of Dexmedetomidine 1.5 μg · kg-1·h-1 before operation	Dexmedetomidine Preemptive Analgesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resting EEG	Resting-state electroencephalography (rsEEG) was recorded at three phases: before dexmedetomidine infusion (non-dosing phase), during dexmedetomidine infusion (DEX phase), and after dexmedetomidine infusion cessation (Cessation phase).	During the whole operation

Secondary Outcomes

Measure	Description	Time Frame
ERP	Event-related potential (ERP) was measured at three phases: before dexmedetomidine infusion (Non-dosing phase), during dexmedetomidine infusion (DEX phase), and after infusion cessation (Cessation phase)	During the whole operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with hip osteoarthritis scheduled for total hip arthroplasty under intrathecal anesthesia; Age 18-70 years; American Society of Anesthesiologists (ASA) physical status classification I-III; Body mass index (BMI) 22-30 kg/m².

Exclusion Criteria:

Pre-existing peripheral or central nervous system disorders; Mental disorders; Cognitive impairment; Emergency surgery; or Hearing impairment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanghai Cui, prof	Contact	+861083199270	+8618196987786	1055885750@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuanwu hospital		Beijing	Beijing Municipality	100053	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided