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NOT YET RECRUITING
NCT07235995
PHASE4

Paracetamol and Mannitol Injection and Postoperative Delirium

Sponsor: Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

Official title: Impact of Paracetamol and Mannitol Injection Analgesia on Postoperative Delirium in Elderly Patients After Non-cardical Surgery: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1092

Start Date

2025-12-01

Completion Date

2027-04-30

Last Updated

2025-11-19

Healthy Volunteers

No

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.

Locations (1)

Xiangya hospital

Changsha, Hunan, China