Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
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.
Detailed Description:
Delirium is a common complication after surgery. It is associated with increased morbidity and mortality, longer intensive care unit (ICU) and hospital stay, prolonged mechanical ventilation, higher risk of institutionalization, and higher healthcare cost. Depending on patient population and screening method, the incidence of delirium in elderly patients admitted to ICU can be as high as 58-76%. The choice of analgesics and the adequacy of pain control are among the modifiable precipitating factors for postoperative delirium (POD). Whether the use of intravenous acetaminophen decreases the occurrence of POD in elderly noncardiac surgical patients admitted to ICU remains inadequately studied.
Objectives: 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.
Study design: A randomized controlled trial. Setting: 34 ICUs from different regions across China. Patients: 1092 elderly patients (≥ 60 years), having noncardiac surgery and admitted to ICU after surgery, are eligible.
Intervention: Patients are randomly assigned to intravenous acetaminophen or sufentanil groups. Intravenous acetaminophen is the analgesic of choice for patients in the acetaminophen group. Intravenous sufentanil is the analgesic of choice for patients in the sufentanil group (control).
Outcomes: The primary endpoint is the incidence of delirium within the first 5 days after surgery. Delirium is assessed using the confusion assessment method for the intensive care unit (CAM-ICU). The secondary endpoints include the level of pain assessed using the Numeric Rating Scale (NRS) on postoperative day 1 to 5 and day 30, 30-day mortality, length of ICU and hospital stay, quality of life assessed on postoperative day 30, cognitive function assessed on postoperative day 30, and biomarkers and neurofunctional testing for delirium.
Predicted duration of the study: 24 months.
Study:
NCT07235995
Study Brief:
Protocol Section:
NCT07235995