Assessing the Time-Course of Dexmedetomidine-Induced Analgesia Via EEG
NCT ID: NCT06946277
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2025-04-25
2025-05-26
Brief Summary
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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.
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Detailed Description
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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 hemodynamic monitoring was performed.
EEG/ERP monitoring: The 64-site EEG and ERP were recorded at different phases
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Dexmedetomidine Preemptive Analgesia
Preemptive Analgesia Of Dexmedetomidine
Preemptive Analgesia Of Dexmedetomidine 1.5 μg · kg-1·h-1 before operation
Interventions
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Preemptive Analgesia Of Dexmedetomidine
Preemptive Analgesia Of Dexmedetomidine 1.5 μg · kg-1·h-1 before operation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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China International Neuroscience Institution
OTHER
Responsible Party
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Locations
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Xuanwu hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CINI-AD-2025-0218
Identifier Type: -
Identifier Source: org_study_id
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