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

NCT ID: NCT06946277

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2025-05-26

Brief Summary

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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

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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

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Total Hip Arthroplasty (THA) Intrathecal Anesthesia Hip Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine Preemptive Analgesia

Group Type EXPERIMENTAL

Preemptive Analgesia Of Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Preemptive Analgesia Of Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China International Neuroscience Institution

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Yanghai Cui, prof

Role: CONTACT

+861083199270 ext. +8618196987786

Facility Contacts

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Yanghai Cui, PHD

Role: primary

83199270 ext. 15010283592

Other Identifiers

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CINI-AD-2025-0218

Identifier Type: -

Identifier Source: org_study_id

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