Delirium in Old Age Clinical Trial
Official title:
Impact of Oral Acetaminophen Analgesia on Postoperative Delirium and Long-term Survival in Elderly Patients After Non-cardiac Surgery: A Randomized Controlled Trial
To investigate the impact of acetaminophen analgesia on the frequency of postoperative delirium and 28 days mortality in elderly patients after noncardiac surgery.
Background: Delirium is a common complication following surgery contributes to adverse
outcomes, including increased mortality and morbidity, longer length of ICU stays, prolonged
mechanical ventilation, and costlier hospitalizations. Previous studies showed that, the
incidence of delirium for seniors patients admitted to ICU can reach up to 58%-75.6%
depending on the patient population and screening instrument. The current protocols for
perioperative opioid use and postoperative pain management may influence the occurrence of
delirium. We hypothesize that the use of oral acetaminophen (OVA) may lead to reduced opioid
consumption and decreased incidence of postoperative delirium.
Objectives: To investigate the impact of acetaminophen analgesia on the frequency of
postoperative delirium and 28 days mortality in elderly patients after noncardiac surgery.
Study design: A randomized and controlled trial. Setting: Departments of critical care
medicine of tertiary hospital (Xiangya) in China.
Patients: 164 elderly patients (≥ 65 years) who are scheduled to admitted to ICU after major
surgery (predicted duration ≥ 2 hours) Intervention: For patients in the acetaminophen group,
oral acetaminophen supplemented dexmedetomidine sedation will be provided after surgery. For
patients in the control group, sufentanil supplemented dexmedetomidine sedation will be
provided after surgery. the other analgesia drugs will be provided as back up in study group.
Primary outcome: Early primary endpoint is the frequency of delirium in the first 5-days
post-surgery. Secondary endpoints include biomark and NeuroMonitoring of delirium, 28days and
in-hospital mortality, length of stay days in ICU and hospital, complication in hospital.
Predicted duration of the study: 2 years.
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