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NCT06653465
Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery: a Randomised Controlled Study
Phase 2/Phase 3 trial testing Acetaminophen in Delirium in Old Age in 1,930 participants. Not yet recruiting.
1 June 2027
Quick facts
| Lead sponsor | RenJi Hospital |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 1,930 |
| Start date | 1 June 2025 |
| Primary completion | 1 June 2027 |
| Estimated completion | 1 July 2027 |
Drugs / interventions tested
- Acetaminophen (Paracetamol) — full drug profile →
- Saline
Conditions studied
- Delirium in Old Age — all drugs for Delirium in Old Age →
Sponsor
RenJi Hospital
Who can join
65 and older, any sex, with Delirium in Old Age. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of postoperative delirium
Time frame: Participants will be followed up during the first 5 postoperative days.
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
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Intravenous acetaminophen for postoperative delirium in older patients recovering from major non-cardiac surgery: a randomised-controlled study protocol.
Zheng M, Wang B, Mao M, Wu Y, et al · · 2025 · PMID 40379334 · DOI 10.1136/bmjopen-2024-097079
Verify or expand the search:
- PubMed search for NCT06653465
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Delirium in Old Age
Currently open trials in the same condition.
- NCT06721819 — The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium · Phase 3 · recruiting
- NCT06216483 — Using EMR Data and AI to Develop a Passive Digital Marker to Predict Postoperative Delirium · NA · active not recruiting
- NCT06100029 — The Effect of Lavender Essential Oil for Delirium in Elderly Intensive Care Unit Patients: Study Protocol · NA · recruiting
- NCT05242419 — A Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery · NA · recruiting
Other RenJi Hospital trials
Trials by the same sponsor.
- NCT07584733 — Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper · Phase 2 · not yet recruiting
- NCT07537725 — EEG-TMS for Postoperative Delirium After Cardiac Surgery · NA · not yet recruiting
- NCT07527936 — A Study of BEN301 Injection in theTreatment of Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
- NCT07343076 — Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE · NA · not yet recruiting
- NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06653465 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RenJi Hospital
- Last refreshed: 1 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06653465.
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