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

Condition(s) studied

Investigational drug(s) / intervention(s)

Preemptive Analgesia Of Dexmedetomidine: Preemptive Analgesia Of Dexmedetomidine 1.5 μg · kg-1·h-1 before operation

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

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