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

China International Neuroscience Institution

Status and phase: Not yet enrolling; Phase 4

Conditions: Hip Osteoarthritis; Intrathecal Anesthesia; Total Hip Arthroplasty (THA)

Treatments: Drug: Preemptive Analgesia Of Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06946277

CINI-AD-2025-0218

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Dexmedetomidine Preemptive Analgesia

Experimental group

Treatment:

Drug: Preemptive Analgesia Of Dexmedetomidine