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Paracetamol and Mannitol Injection and Postoperative Delirium

NCT07235995 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1092

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

  • Postoperative Delirium
  • Elderly
  • Non Cardiac Surgery

Interventions

DRUG

Acetaminophen group

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.

DRUG

Sufentanil group

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.

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • Yixiong Li · Central South University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-01-31
Completion
2027-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07235995 on ClinicalTrials.gov