Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery

NCT06653465 | Not Yet Recruiting Phase 2

• 1 other identifier: LY-2023-239
• Study Type: interventional
• Target: 1,930
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Delirium in Old Age

Keywords

postoperative delirium; acetaminophen; elderly patient

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will be followed up during the first 5 postoperative days.

Secondary Outcomes (5)

• Delirium type

  Participants will be followed up during the first 5 postoperative days.

• Delirium severity

  Participants will be followed up during the first 5 postoperative days.

• Pain scores

  Participants will be followed up during the first 5 postoperative days.

• Total opioid consumption

  Participants will be followed up during the first 5 postoperative days.

• Delirium duration

  Participants will be followed up during the first 5 postoperative days.

Other Outcomes (3)

• Cognitive function

  Cognitive function will be evaluated on the fifth day after operation.

• Length of days in ICU and hospital after surgery

  one month

• All cause mortality

  one month

Study Arms (2)

intravenous aceteminophen group

EXPERIMENTAL

50 ml contains 500 mg of acetaminophen will be administered for the first dose when the surgical suture begin at the end of surgery and thereafter repeated every 6 hours for the following 7 doses using automatic intravenous pump (4g acetaminophen diluted with 0.9% saline to 400 ml), and every bolus of 50 ml will be finished within 10 minutes.

Drug: Acetaminophen

saline placebo group

PLACEBO COMPARATOR

50 ml 0.9% saline will be administered for the first dose placebo when the surgical suture begin at the end of surgery and thereafter repeated every 6 hours for the following 7 doses using automatic intravenous pump (400ml 0.9% saline without acetaminophen), and every bolus of 50 ml will be finished within 10 minutes.

Drug: Saline

Interventions

Acetaminophen DRUG

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.

intravenous aceteminophen group

Saline DRUG

Saline, a kind of crystalloid widely used in clinical treatment.

saline placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Acetaminophen; Sodium Chloride

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• LIQUN YANG, MD

  Anesthesiology, Renji Hospital, Shanghai Jiao Tong University, School of Medicine Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LIQUN YANG, MD

CONTACT

15921969001; lqyang72721@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF