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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Temporal Profile of Dexmedetomidine-Induced Analgesia Via EEG Signatures in Brain
- ClinicalTrials.gov ID
- NCT06946277
- Acronym / sponsor ID
- CINI-AD-2025-0218
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 25 Nov 2026 (estimated)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 26 May 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Preemptive Analgesia | Experimental | Drug: Preemptive Analgesia Of Dexmedetomidine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pre-existing peripheral or central nervous system disorders; Mental disorders; Cognitive impairment; Emergency surgery; or Hearing impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preemptive Analgesia Of DexmedetomidinePreemptive Analgesia Of Dexmedetomidine 1.5 μg · kg-1·h-1 before operation | Drug | Dexmedetomidine Preemptive Analgesia |
Primary outcome
Change From Baseline in the Composite Prefrontal Synchronization Index (PFC-Sync Index)
Time frame: 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
2 secondary outcomes
ERP
Time frame: During the whole operation
Resting EEG
Time frame: During the whole operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanghai Cui, prof (+861083199270 ext. +8618196987786, 1055885750@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Composite Prefrontal Synchronization Index (PFC-Sync Index) (time frame: Baseline (15-minute resting state prior to any intervention) and 30 minutes after the start of DEX infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.