About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.).
Trial design
Parallel
Treatments tested in this trial
Acetaminophen
DrugAcetaminophen, 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.
Saline
DrugSaline, a kind of crystalloid widely used in clinical treatment.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative delirium
Delirium will be assessed by the trained investigators twice daily, from 8-10 AM and from 5-7 PM, starting from postoperative day 1 using 3-minute Confusion Assessment Method (3D-CAM) or CAM-ICU for intubated patients. Immediately before assessing delirium, sedation or agitation was assessed using Richmond Agitation-Sedation Scale (RASS). If the patient was too deeply sedated or unarousable (RASS -4 or -5), delirium assessment was aborted and the patient was recorded as comatose.
Secondary outcomes
Delirium type
Patients with delirium were classified into three motoric subtypes. Hyperactive delirium was defined when RASS was consistently positive (+1 to +4); hypoactive delirium was defined when RASS was consistently neutral or negative (-3 to 0); and mixed delirium was defined when some RASS scores were positive (+1 to +4) and some RASS scores were neutral or negative (-3 to 0).
Delirium severity
Delirium rating scale 98 revised (DRS-R-98) will be used to evaluate severity of delirium. DRS-R-98 consists of 16 items, including 13 items to assess severity of delirium and 3 diagnostic items. The total severity score range from zero (best) to 39 (worst).
Pain scores
Pain scores will be assessed using numerical rating scale (NRS) once daily, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".
Total opioid consumption
Amount of intravenous and/or oral opioid consumption for analgesia will be recorded.
Other outcomes
Cognitive function
Cognitive function will be evaluated with Mini-Mental State Examination (MMSE) score that ranges from zero (worst) to 30 (best).
Length of days in ICU and hospital after surgery
Length of stay in ICU and hospital after surgery will be collected from electronic medical records.
All cause mortality
Locations
Sponsors and contacts
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