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NCT07235995
Acetaminophen-Mannitol Injection and Postoperative Delirium
Conditions: Postoperative Delirium
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 1092
Sponsor: Xiangya Hospital of Central South University
Location: Xiangya hospital Changsha Hunan
Summary
The aim of this multicenter randomized controlled study is to evaluate the effect of an intravenous acetaminophen-mannitol opioid-sparing analgesic strategy on the cumulative incidence of POD, compared with an intravenous sufentanil-based opioid analgesic strategy.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 60 years;
* Admitted to ICU after a noncardiac surgical procedure
* Signed informed consent form
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded.
* Preoperative medical history: schizophrenia, epilepsy, Parkinson's disease, end stage renal disease, or end stage liver disease.
* Inability to communicate preoperatively due to coma, severe dementia, or language disorder.
* Patients with traumatic brain injury or undergoing neurosurgical procedures.
* Positive screening result for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methamphetamine, methadone, or methylenedioxymethamphetamine).
* Participation in another clinical study within 30 days prior to surgery, or planned concurrent participation in another clinical study.
* Positive preoperative CAM-ICU assessment indicating delirium.
* Occurrence of intraoperative or postoperative complications before randomization, and the investigator deems the subject unsuitable for study participation.
* Hepatic dysfunction at screening, defined as ALT or AST \>3× the local laboratory upper limit of normal (ULN).
* Intolerance or contraindication to acetaminophen or the protocol analgesics.
Source: ClinicalTrials.gov (NCT07235995). StuddyBuddy aggregates publicly available trial information.