Paracetamol and Mannitol Injection and Postoperative Delirium (NCT07235995) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Paracetamol and Mannitol Injection and Postoperative Delirium
China1,092 participantsStarted 2025-12-01
Plain-language summary
The aim of this multi-center RCT is to investigate the effect of intravenous acetaminophen (paracetamol and mannitol injection) on postoperative delirium, comparing with intravenous sufentanil, in elderly noncardiac surgical patients admitted to ICU.
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Rate of delirium
Timeframe: postoperative 1- 5 days
Trial details
NCT IDNCT07235995
SponsorXiangya Hospital of Central South University