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Acetaminophen-Mannitol Injection and Postoperative Delirium
Sponsor: Xiangya Hospital of Central South University
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
Conditions
Interventions
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.
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