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Could a common painkiller keep seniors Clear-Headed after surgery?

NCT ID NCT07235995

Symptom relief Sponsor: Xiangya Hospital of Central South University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will test whether giving paracetamol (a common painkiller) instead of a strong opioid (sufentanil) can reduce confusion and delirium in elderly patients after non-cardiac surgery. About 1,092 patients aged 60 and older will be randomly assigned to receive either paracetamol or sufentanil for pain control in the ICU. The main goal is to see if paracetamol leads to fewer cases of postoperative delirium.

What this could mean

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

Active substance
paracetamol (acetaminophen) and mannitol injection
What this could lead to
If it works, this could offer a safer painkiller option for older patients after surgery, reducing their risk of confusion and other side effects.
What could go wrong
This is a phase 4 trial, so the drugs are already approved, but it is still possible that paracetamol does not reduce delirium better than the standard opioid. The study has not started yet, so results are pending.

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 1,092 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Apr 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

60 years and older

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: * Age ≥ 60 years; * Admitted to ICU after a noncardiac surgical procedure * Moderate to severe acute pain, with a postoperative pain score ≥ 5 based on the 11-point Numerical Pain Rating Scale (NPRS) * Signed informed consent form Exclusion Criteria: * Preoperative medical history: schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis * History of psychiatric disease or significant neurocognitive disorder such as dementia or retardation, making POD assessment impossible * Language or communication barrier making POD assessment impossible * Intracranial surgery * Severe hepatic dysfunction prohibiting the use of acetaminophen per the standard of care * Participation in a competing study within 30d * Patients experienced intraoperative or postoperative complications, and the investigator determined the subject was unsuitable to continue participation in the study * Intolerant to paracetamol or opioid drugs

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Conditions

The condition(s) this trial relates to.

Emergence Delirium

As listed by the trial registrant

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

Elderly Non-cardiac surgery Postoperative delirium

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

  • Xiangya hospital

    Changsha, Hunan, 410000, China

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