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Pain ManagementPhase 4NCT06671327

Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

A Phase 4 study testing Preemptive Dexmedetomidine injection and Sodium Chloride 0.9% Inj in people with Pain Management and Noncardiac Surgery, run by China International Neuroscience Institution at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Background:Preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Pain Management, Noncardiac Surgery
What is being tested?
Preemptive Dexmedetomidine injection and Sodium Chloride 0.9% Inj
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
208 participants
Where
1 siteChina
Study dates
3 Apr 2025to 30 Jun 2025
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years to 85 years old,
  • body mass index (BMI,calculated as weight in kilograms divided by height in meters squared): 18.5~35.
  • ASA (American Society of Anesthesiologists) Grade I- III;
  • Scheduled for non-cardiac surgery undergoing general anesthesia
  • expected duration of operation 0.5~3 h.

Who cannot join

  • disagreed to participate;
  • body mass index (BMI) of greater 35
  • American Society of Anesthesiologists (ASA) classification 4 or above;
  • previous severe central nervous systemheart, liver, kidney or and lung dysfunction ;
  • diagnosed neuropsychological disorders, that is, schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis，Alzheimer's disease and other autonomic disorders of patients affecting EEG outcomes;
  • comatose, dementia, or language barrier which impeded communication and assessment;
  • history of neurosurgical procedures;
  • Systolic blood pressure continuously lower than 85mmHg or higher than 180mmHg; heart rate continuously lower than 45 times / min; sever arrhythmia need intervation and implantable pacemaker.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanghai Cui, prof contact

+861083199270 ext. +8618196987786

1055885750@qq.com

China1 site

  • Xuanwu hospital

    Beijing, Beijing Municipality, 100053

    Yanghai Cui, PHD, 83199270 ext. 15010283592, 1055885750@qq.com

    Tianlong Wang, Doctor, 15910851623 ext. 15910851623, w_tl5595@yeah.net

Other trials in China

About this study

Official title: Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain After Noncardiac Surgery

Background:Preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. Preemptive analgesia of dexmedetomidine (DEX) in the epidural and subarachnoid space can effectively prevent the central sensitization, and significantly reduce the phantom limb pain, residual pain after one year of lower limb amputation.

Objective: To investigate the per-operative effects of DEX preemptive analgesia.

Method:The patients scheduled noncardiac surgery undergoing general anesthesia were selected and divided into DEX group and Placebo group randmized. The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and 15min after induction. The Placebo group was infused with equal amounts of normal saline.The Coprimary efficacy outcome was a composite of analgesia effect, one is the Compliance Rate of IOC2 target in intra-operation, another is the the rate of none-to-slight post-operative pain assessed with the p-NRS≦3 at 12 hours after surgery [Pain numeric rating scale was assessed with the (Numeric Rating Scale, p-NRS)].

Read the detailed description

Background:Preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. Preemptive analgesia of DEX in the epidural and subarachnoid space can effectively prevent the central sensitization, and significantly reduce the phantom limb pain, residual pain after one year of lower limb amputation.

Objective: To investigate the per-operative effects of DEX preemptive analgesia.

Being tested
Preemptive Dexmedetomidine injection, Sodium Chloride 0.9% Inj
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preemptive Dexmedetomidine injectionDrug

    Also called Preemptive Dex

    The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and after induction continue infusion 15min.

  • Sodium Chloride 0.9% InjDrug

    Also called Preemptive Sodium Chloride 0.9%

    The Placebo group was infused with equal amounts of isochronous normal saline.

Study groups in NCT06671327
Study groupRoleWhat they receive
Dexmedetomidine groupExperimentalThe DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and after induction continue infusion 15min.
Receives: Drug: Preemptive Dexmedetomidine injection
Placebo groupPlacebo comparatorthe Placebo group was infused with equal amounts of 0.9% Sodium Chloride
Receives: Drug: Sodium Chloride 0.9% Inj

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The coprimary efficacy outcome

    The rate of intro-operative IOC2 target reachment

    Measured: During the whole operation

  2. The coprimary efficacy outcome

    The rate of none-to-slight post-operative pain, assessed with the (Numeric Rating Scale)p-NRS< =3 at 24h post-opertively.

    Measured: post-operative 24 hours

  3. The primary safety outcome

    Adverse events and safety outcomes within during 48 h post-operation: hypotension, Hypertension,Bradycardia,Tachycardia,Respiratory depression,Pulse oxygen desaturation and the number of patients which need intervention.

    Measured: During 48 h post-operation

Secondary outcomes (13)

  1. SBP

    systolic blood pressure(intraoperative hemodynamics)

    Measured: During the whole operation

  2. DBP

    dystolic blood pressure(intraoperative hemodynamics)

    Measured: During the whole operation

  3. MAP

    mean arterial pressure(intraoperative hemodynamics)

    Measured: During the whole operation

  4. HR

    Heart rate (intraoperative hemodynamics)

    Measured: During the whole operation

  5. Bispectral index

    Bispectral index

    Measured: During the whole operation

  6. EMG

    Electromyogram Index

    Measured: During the whole operation

  7. pNRS at Hour 0, Hour 24, Hour 48, and the Day 7 postoperatively

    Record and compared the pNRS at Hour 0, Hour 24, Hour 48, and the Day 7 postoperatively. (The p-NRS was an 11-point scale with 0 indicating no pain and 10 equaled worst pain).

    Measured: post-operation p-NRS until 7 days(inculde Hour 0, Hour 24, Hour 48, and the Day 7 timepoints)

  8. mPONV

    modified postoperative nausea vomiting (mPONV) score at postoperative immediately (0 hour)and 24 hours post-operatively.

    Modified PONV Scoring Criteria:

    0 points: No nausea or vomiting.

    1. point: Nausea present, no vomiting.
    2. points: Nausea with one vomiting episode. Additional points: +1 per additional vomiting episode (e.g., 4 vomiting episodes = 5 points).

    Measured: Postoperative immediately and until 12 hours post-operatively

  9. The accumulation of analgesia consumption

    The accumulation of analgesia consumption was used to describe oxycodone accumulation (oral administration of oxycodone 5 mg for each complaint of pain) at Hour 24, Hour 48, and the Day 7 after surgery.

    Measured: Hour 24, Hour 48, and the Day 7 after surgery

  10. Dizziness

    Dizziness at Hour 0, Hour 24 and the Hour 48 post-operatively

    Measured: Hour 0, Hour 24 and the Hour 48 post-operatively

  11. Agitation

    Agitation immediately afer surgery(Hour 0 post-operation)

    Measured: immediately afer surgery(Hour 0 post-operation)

  12. The rate of exhaust

    The rate of exhaust at first 24hours post-operation

    Measured: until 24hours post-operation

  13. Extubation time

    Extubation time

    Measured: after operation immediately

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2024
  2. Study start3 Apr 2025 (estimated)
  3. Primary completion23 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06671327
Sponsor's protocol ID
CINI-AD-2024-0112
Status last verified
Mar 2025
First submitted
25 Jul 2024
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang X, Chang H, Qi W, Wang H, Huang Y, Wu Z, Wang Q, Jiang W, Wang T. Dexmedetomidine Preemptive Analgesia on Intra- and Postoperative Pain in Noncardiac Surgery: A Randomized, Double-Blind, Controlled Study. Anesth Analg. 2026 May 28. doi: 10.1213/ANE.0000000000008078. Online ahead of print.

    PubMed 42207991

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Preemptive Dexmedetomidine injection and Sodium Chloride 0.9% Inj in people with Pain Management and Noncardiac Surgery, 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 5 inclusion and 8 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 9 Apr 2025. 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. Some participants in this study may receive a placebo. 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?

The coprimary efficacy outcome (time frame: During the whole operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06671327, which also lists 1 linked publication.

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 9 Apr 2025.

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