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RECRUITING
NCT07235995
PHASE4

Acetaminophen-Mannitol Injection and Postoperative Delirium

Sponsor: Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

The aim of this multicenter randomized controlled study is to evaluate the effect of an intravenous acetaminophen-mannitol opioid-sparing analgesic strategy on the cumulative incidence of POD, compared with an intravenous sufentanil-based opioid analgesic strategy.

Official title: Effect of Analgesia With Acetaminophen-Mannitol Injection on Postoperative Delirium in Older Patients Undergoing Non-cardiac Surgery: Protocol for an Open-label Randomized Controlled Trial

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1092

Start Date

2026-02-02

Completion Date

2027-04-30

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DRUG

Acetaminophen group

The pain in this group is controlled using acetaminophen-mannitol (Paracetamol and Maninitol Injection, Yichang Renfu Medicine Co., Ltd., China), 500 mg, intravenous bolus, every 6 hours for the first 48 hours after randomization. The severity of pain is assessed using NRS/CPOT every 15 minutes during the first hour after randomization with study drug infusion and then once every 12 hours needed.The NRS will be used for awake patients, and the CPOT will be used for mechanically ventilated patients.

DRUG

Sufentanil group

The 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/CPOT every 15 minutes during the first hour after randomization with study drug infusion and then once every 12 hours needed.The NRS will be used for awake patients, and the CPOT will be used for mechanically ventilated patients.

Locations (1)

Xiangya hospital

Changsha, Hunan, China