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

ConditionsTotal Hip Arthroplasty (THA)Intrathecal AnesthesiaHip Osteoarthritis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChina International Neuroscience Institution

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Preemptive Analgesia Of Dexmedetomidine

    Drug

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Dexmedetomidine Preemptive AnalgesiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in the Composite Prefrontal Synchronization Index (PFC-Sync Index)

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

Time frame
Baseline (15-minute resting state prior to any intervention) and 30 minutes after the start of DEX infusion.

Secondary outcomes

1

ERP

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)

Time frame
During the whole operation
2

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).

Time frame
During the whole operation

Other outcomes

Sponsors and contacts

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China International Neuroscience Institution

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: