Acetaminophen-Mannitol Injection to See If It Reduces Postoperative Delirium

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial in 34 ICUs in China compares an intravenous acetaminophen-mannitol opioid-sparing analgesic strategy to an intravenous sufentanil-based analgesic approach in adults aged 60 and over after noncardiac surgery. The primary goal is to measure the cumulative incidence of postoperative delirium during ICU stay. Outcomes focus on delirium risk, pain control, and related clinical factors in an elderly surgical population. The study seeks to determine whether an acetaminophen-based strategy can reduce delirium while maintaining effective analgesia. Enrollment targets 1,092 participants to assess potential benefits across diverse centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xiangya hospital
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Lina Zhang, Dr.
• Email: zln7095@163.com
• Phone: 86+15874875763

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intranasal insulin to reduce delirium after heart surgery with a heart-lung machine

  This study tests whether giving intranasal insulin can reduce glycemic swings and delirium after elective heart surgery with cardiopulmonary bypass.

  Recruiting Fujian Medical University Union Hospital · Fuzhou, Fujian · NCT07893353

• Postoperative Pain Control in Elderly Knee Replacement

  This study tests two pain-management methods after knee replacement in adults 60 and older to see which one reduces delirium and improves recovery.

  Recruiting Ankara City Hospital Bilkent · Ankara, Çankaya · NCT07849517

• Perioperative transcranial photobiomodulation to see if it helps older adults recover brain function after surgery

  This trial tests whether applying light therapy to the brain around the time of surgery can reduce delayed brain recovery in older patients with pre-existing cognitive decline.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07736092

• Risk of delirium and cognitive problems after TUR-P in older adults

  This study tests whether certain perioperative factors can predict delirium and postoperative cognitive dysfunction in people aged 65 and older undergoing transurethral resection.

  Recruiting Muğla Sıtkı Koçman University · Muğla · NCT07719712

• How anesthesia type affects thinking after bariatric sleeve surgery

  This observational study tests whether intravenous anesthesia or inhalational anesthesia leads to different cognitive outcomes after sleeve gastrectomy in adults with obesity.

  Recruiting Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Istanbul, Sancaktepe · NCT07637357

• Propofol vs Sevoflurane Delirium in Postoperative Patients: A Large Look Back at Anesthesia Choices

  This study tests whether the choice of anesthesia technique during elective surgery affects the risk of delirium after surgery in adults.

  Recruiting at 2 sites Charite University, Berlin, Germany · Berlin and 1 other locations · NCT07612579

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.