Total Hip Arthroplasty (THA)Phase 4NCT06946277
Assessing the Time-Course of Dexmedetomidine-Induced Analgesia Via EEG
A Phase 4 study testing Preemptive Analgesia Of Dexmedetomidine in people with Total Hip Arthroplasty (THA) and Intrathecal Anesthesia, run by China International Neuroscience Institution at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Total Hip Arthroplasty (THA), Intrathecal Anesthesia, Hip Osteoarthritis
- What is being tested?
- Preemptive Analgesia Of Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2026to 26 May 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pre-existing peripheral or central nervous system disorders; Mental disorders; Cognitive impairment; Emergency surgery; or Hearing impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu hospital
Beijing, Beijing Municipality, 100053
Yanghai Cui, PHD, 83199270 ext. 15010283592, 1055885750@qq.com
About this study
Official title: Mapping the Temporal Profile of Dexmedetomidine-Induced Analgesia Via EEG Signatures in Brain
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:
Read more
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.
Read the 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
- Being tested
- Preemptive Analgesia Of Dexmedetomidine
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemptive Analgesia Of DexmedetomidineDrug
Preemptive Analgesia Of Dexmedetomidine 1.5 μg · kg-1·h-1 before operation
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Preemptive Analgesia | Experimental | Not described Receives: Drug: Preemptive Analgesia Of Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (15-minute resting state prior to any intervention) and 30 minutes after the start of DEX infusion.
Secondary outcomes (2)
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)
Measured: During the whole operation
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).
Measured: During the whole operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start25 Nov 2026 (estimated)
- Primary completion25 May 2027 (estimated)
- Study completion26 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946277
- Sponsor's protocol ID
- CINI-AD-2025-0218
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided