New drug cocktail aims to cut Post-Surgery pain in half
NCT ID NCT07523321
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 274 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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- Can a Mini-Dose drug combo rescue Post-Surgery sleep for sleep apnea patients?
- Predicting pain: a new model may tailor Post-Surgery relief