NCT07235995

Brief Summary

The aim of this multi-center RCT is to investigate the effect of intravenous acetaminophen (paracetamol and mannitol injection) on postoperative delirium, comparing with intravenous sufentanil, in elderly noncardiac surgical patients admitted to ICU.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,092

participants targeted

Target at P75+ for phase_4

Timeline
12mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Dec 2025Apr 2027

First Submitted

Initial submission to the registry

November 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

November 13, 2025

Last Update Submit

November 17, 2025

Conditions

Postoperative DeliriumElderlyNon Cardiac Surgery

Keywords

Postoperative deliriumIntravenous acetaminophenElderlyNoncardiac surgical patients

Outcome Measures

Primary Outcomes (1)

  • Rate of delirium

    Delirium assessed using CAM-ICU every 12 hours (8am, 8 pm) during postoperative days 1-5 and RASS transform at any time

    postoperative 1- 5 days

Secondary Outcomes (7)

  • All-cause mortality

    30-day after surgery

  • Severity of pain

    postoperative days 1-5

  • Length of ICU stay

    immediately after surgery

  • Length of hospital stay

    immediately after surgery

  • Quality of life of 30-day survivors

    day 30 after surgery

  • +2 more secondary outcomes

Other Outcomes (3)

  • Sleep quality

    postoperative days 1-5

  • Biomarker of delirium

    Postoperative day 1

  • Neuro monitoring of delirium

    Postoperative days 1-5

Study Arms (2)

Acetaminophen group

EXPERIMENTAL

Intravenous acetaminophen is the analgesic of choice for patients in the acetaminophen group

Drug: Acetaminophen group

Sufentanil group

ACTIVE COMPARATOR

Intravenous sufentanil is the analgesic of choice for patients in the sufentanil group

Drug: Sufentanil group

Interventions

Acetaminophen groupDRUG

The pain in this group is controlled using acetaminophen (Paracetamol and Maninitol Injection, Yichang Renfu Medicine Co., Ltd., China), 500 mg, intravenous bolus, every 6 hours for the first 48 hours postoperatively. The severity of pain is assessed using NRS every 15 minutes during the first hour following ICU admission and then once every 12 hours needed.

Acetaminophen group
Sufentanil groupDRUG

he pain in this group is controlled using sufentanil (Yichang Renfu Medicine Co., Ltd., China) intravenous infusion with a rate of 0.05 μg/kg/h. The severity of pain is assessed using NRS every 15 minutes during the first hour following ICU admission and then once every 12 hours needed.

Sufentanil group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years;
  • Admitted to ICU after a noncardiac surgical procedure
  • Moderate to severe acute pain, with a postoperative pain score ≥ 5 based on the 11-point Numerical Pain Rating Scale (NPRS)
  • Signed informed consent form

You may not qualify if:

  • Preoperative medical history: schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis
  • History of psychiatric disease or significant neurocognitive disorder such as dementia or retardation, making POD assessment impossible
  • Language or communication barrier making POD assessment impossible
  • Intracranial surgery
  • Severe hepatic dysfunction prohibiting the use of acetaminophen per the standard of care
  • Participation in a competing study within 30d
  • Patients experienced intraoperative or postoperative complications, and the investigator determined the subject was unsuitable to continue participation in the study
  • Intolerant to paracetamol or opioid drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya hospital

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Yixiong Li

    Central South University

    STUDY CHAIR

Central Study Contacts

Lina Zhang, Dr.

CONTACT

86+15874875763zln7095@163.com

Milin Peng, Dr.

CONTACT

86+15211040348pengmilin@csu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 19, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)