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New drug cocktail aims to cut Post-Surgery pain in half

NCT ID NCT07523321

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving a combination of two drugs, dexmedetomidine and esketamine, during and after spinal surgery can reduce moderate-to-severe pain in the first three days after the operation. About 274 adults aged 40 to 80 having spine surgery will be randomly assigned to receive the drug combo or a placebo. The goal is to see if this approach leads to better pain control and fewer side effects than current methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexmedetomidine and esketamine (drug combination)
What this could lead to
If it works, this could offer a better way to manage pain after spinal surgery, reducing the need for strong opioids and improving recovery.
What could go wrong
This is a Phase 4 trial, but it's still early and small (274 people). The drug combo may not work better than standard care, and side effects like low heart rate or confusion are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 274 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged \>= 40 years but \< 80 years; 2. Scheduled to undergo elective posterior cervical, thoracic, or lumbar spine surgery with an expected duration \>= 2 hours under general anesthesia; 3. Required patient-controlled intravenous analgesia (PCIA) after surgery. Exclusion Criteria: 1. Uncontrolled preoperative hypertension (ward systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg); 2. Severe bradycardia (heart rate \<= 50 bpm), sick sinus syndrome, atrioventricular block of grade II or higher without pacemaker implantation, a history of myocardial infarction within one year, or presence of rapid ventricular arrhythmia; 3. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis, or prresence of intracranial hypertension; 4. Uncontrolled hyperthyroidism or pheochromocytoma; 5. Inability to communicate due to coma, severe dementia, or language barrier; 6. Severe cardiac insufficiency (preoperative left ventricular ejection fraction \< 30% or New York Heart Association Functional classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (preoperative dialysis), or American Society of Anesthesiologists physical status \>= IV; 7. Other conditions that are considered unsuitable for study participation.

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.