Hip Osteoarthritis, Intrathecal Anesthesia, Total Hip Arthroplasty (THA)
Conditions
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. 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
Interventions
DRUGPreemptive Analgesia Of Dexmedetomidine
Preemptive Analgesia Of Dexmedetomidine 1.5 μg · kg-1·h-1 before operation
Sponsors
China International Neuroscience Institution
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Composite Prefrontal Synchronization Index (PFC-Sync Index) | Baseline (15-minute resting state prior to any intervention) and 30 minutes after the start of DEX infusion. | Change From Baseline in the Composite Prefrontal Synchronization Index (PFC-Sync Index) at 30 Minutes Post-DEX Infusion. The Prefrontal Synchronization Index (PFC-Sync Index) is a composite EEG biomarker quantifying dexmedetomidine (DEX)-induced cortical state changes in the prefrontal cortex. It integrates two complementary neurophysiological metrics-delta-band spectral power and permutation entropy (PE)-into a single standardized score to reflect the degree of neural synchronization and reduced signal complexity. Calculation: For each participant at each time point, the PFC-Sync Index is computed as: PFC-Sync Index = (Z(δ-Power) + (-Z(PE))) / 2 Where: Z(δ-Power): The standardized (Z-score) value of the absolute delta-band (1-4 Hz) power, derived from EEG electrodes over the prefrontal cortex (e.g., Fp1, Fp2, F3, F4). Z(PE): The standardized (Z-score) value of the permutation entropy, a non-linear measure of signal regularity and complexity, calculated from the same prefrontal EEG el |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ERP | During the whole operation | 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) |
| Resting EEG | During the whole operation | 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). |
Countries
China
Contacts
CONTACTYanghai Cui, prof
Outcome results
None listed