Assessing the Time-Course of Dexmedetomidine-Induced Analgesia Via EEG
Mapping the Temporal Profile of Dexmedetomidine-Induced Analgesia Via EEG Signatures in Brain
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2025
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2025
CompletedStudy Start
First participant enrolled
April 25, 2025
CompletedFirst Posted
Study publicly available on registry
April 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2025
CompletedApril 27, 2025
April 1, 2025
1 month
April 11, 2025
April 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 (1)
ERP
During the whole operation
Study Arms (1)
Dexmedetomidine Preemptive Analgesia
EXPERIMENTALInterventions
Preemptive Analgesia Of Dexmedetomidine 1.5 μg · kg-1·h-1 before operation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pre-existing peripheral or central nervous system disorders; Mental disorders; Cognitive impairment; Emergency surgery; or Hearing impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuanwu hospital
Beijing, Beijing Municipality, 100053, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2025
First Posted
April 27, 2025
Study Start
April 25, 2025
Primary Completion
May 25, 2025
Study Completion
May 26, 2025
Last Updated
April 27, 2025
Record last verified: 2025-04