Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetaminophen, Saline.
- Who it may be relevant to
- Registry conditions: Delirium in Old Age. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery: a Randomised Controlled Study
Overview
Investigators propose this multi-center randomised controlled study to test the preventive effect of intravenouse acetaminophen in delirium over 5 postoperative days among older patients recovering from major non-cardiac surgery.
Detailed description
Delirium is a common complication in elderly patients after major surgeries and can lead to poor outcomes such as neurocognitive decline. Acetaminophen is a widely used adjuvant for perioperative multimodal analgesia. It can effectively alleviate postoperative pain, promote opioid-sparing and exert anti-neuroinflammatory response, showing strong potential for preventing postoperative delirium. There is evidence that intravenous acetaminophen reduces delirium in older patients following cardiac surgery, but its effectiveness is inconclusive among non-cardiac surgical patients. Investigators propose this multi-center, randomized, placebo-controlled, parallel-group trial in patients aged \>65 years old scheduled for non-cardiac major surgery with general anesthesia expected to last at least 2 h. A total of 1930 elderly patients will be enrolled and randomized at 1:1 ratio to acetaminophen or saline placebo groups, stratified by age, education level, and trial site with random-sized blocking. Acetaminophen or saline will be given when the surgical suture begin at the end of surgery and thereafter a total of 7 doses within 48h after surgery. The primary outcome will be the incidence of delirium, assessed twice daily, through the five postoperative days. Secondary outcomes will include pain scores with movement, opioid use within the first 48 postoperative hours, severity of delirium, ICU and hospital lengths of stay.
Interventions
- Drug Acetaminophen
Acetaminophen, which has similarly effects with NSAIDs in terms of inhibition of cyclooxygenase COX1, COX2 and COX3, is widely used as adjuvant for perioperative multimodal analgesia. - Drug Saline
Saline, a kind of crystalloid widely used in clinical treatment.
Primary outcome measures
- Incidence of postoperative delirium [Time frame: Participants will be followed up during the first 5 postoperative days.]
Secondary outcome measures (5)
- Delirium type [Time frame: Participants will be followed up during the first 5 postoperative days.]
- Delirium severity [Time frame: Participants will be followed up during the first 5 postoperative days.]
- Pain scores [Time frame: Participants will be followed up during the first 5 postoperative days.]
- Total opioid consumption [Time frame: Participants will be followed up during the first 5 postoperative days.]
- Delirium duration [Time frame: Participants will be followed up during the first 5 postoperative days.]
Eligibility criteria
Inclusion criteria
- Age ≥ 65 years.
- Scheduled for non-cardiac major surgery with general anesthesia that is expected to last more than 2h.
- ASA Physical Status I-III.
- Weight >50 kg.
- Written informed consent.
Exclusion criteria
- Pre-existing neuropsychiatric diseases (Alzheimer's disease, Schizophrenia, Parkinson's Disease, Seizures, etc.).
- Pre-existing cognitive impairment (MMSE<18).
- Preoperative delirium.
- Severe circulatory instability (preoperative left ventricular ejection fraction less than 30%, unstable angina, severe coronary artery disease, sick sinus syndrome, etc.).
- Contraindication to the acetaminophen use, including serum creatinine > 177µmol/L or aminotransferses > 3 times the upper limit of normal.
- Alcohol or drug abuse within a year before surgery.
- Inability to communicate because of severe visual/auditory dysfunction or language barrier.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Zheng M, Wang B, Mao M, Wu Y, Wang Z, Yang L. Intravenous acetaminophen for postoperative delirium in older patients recovering from major non-cardiac surgery: a randomised-controlled study protocol. BMJ Open. 2025 May 15;15(5):e097079. doi: 10.1136/bmjopen-2024-097079. PMID 40379334
Identifiers
NCT: NCT06653465 · LY-2023-239