NCT06946277

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

Mapping the Temporal Profile of Dexmedetomidine-Induced Analgesia Via EEG Signatures in Brain

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: China International Neuroscience Institution · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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. 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

• Total Hip Arthroplasty (THA)
• Intrathecal Anesthesia
• Hip Osteoarthritis

Interventions

Type	Name	Description
DRUG	Preemptive Analgesia Of Dexmedetomidine	Preemptive Analgesia Of Dexmedetomidine 1.5 μg · kg-1·h-1 before operation

Timeline

• Start date: 2025-04-25
• Primary completion: 2025-05-25
• Completion: 2025-05-26
• First posted: 2025-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: China