This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ketorolac in 360 patients with Stanford Type A aortic dissection, conducted between 2025 and 2027. Participants will receive either ketorolac (60 mg intramuscularly \[IM\] preoperatively and 30 mg twice daily \[BID\] for two days postoperatively) or placebo in addition to standard care. Study outcomes include composite clinical endpoints, postoperative complications, and adverse events, which will be assessed through clinical evaluations, laboratory testing, and imaging studies at predefined intervals up to 90 days. The objective of this trial is to determine whether perioperative administration of ketorolac improves clinical outcomes in this patient population.
Patients with Stanford Type A aortic dissection confirmed by imaging and scheduled for emergency surgery.
Patients who are unable to eat independently or require prolonged fasting.
Parallel
Ketorolac
Drugpatients in the experimental group will receive ketorolac treatment for Stanford Type A aortic dissection, consisting of a 60mg intramuscular injection preoperatively followed by 30mg twice daily for two days postoperatively, while maintaining standard baseline therapies including analgesia, blood pressure control, and subsequent cardiovascular surgical management.
0.9 % saline
Drug0.9% saline
Composite Endpoint: Mortality, Malperfusion Syndrome, Permanent Organ Dysfunction, Unplanned Cardiac Reoperation, and Prolonged Hospitalization
The composite endpoint includes death (the worst outcome); malperfusion syndrome (including myocardial ischemia, stroke, lower limb paralysis, acute abdominal syndrome, renal failure requiring temporary dialysis, or symptoms and signs of limb ischemia); permanent dialysis, tracheostomy, or neurological deficits at discharge; postoperative mechanical circulatory support or unplanned cardiac reoperation (excluding reoperation for bleeding); postoperative cardiac arrest, multiple organ failure, or mechanical ventilation support for more than 72 hours; and postoperative hospital stay of 91 days or longer.
erythrocyte sedimentation rate (ESR)
erythrocyte sedimentation rate (ESR), an indicator of systemic inflammation that reflects the rate at which red blood cells settle in a vertical tube over a specified period. Elevated ESR levels may suggest ongoing inflammatory responses, infection, or tissue injury
The perioperative use of opioids
The perioperative use of opioids such as fentanyl and remifentanil is also assessed
C-reactive protein (CRP)
C-reactive protein (CRP), an acute-phase protein synthesized by the liver that rises rapidly in response to infection, inflammation, or tissue injury. CRP serves as a sensitive biomarker of systemic inflammatory response and will be used to assess the perioperative inflammatory status in patients with Stanford Type A aortic dissection.
interleukin-6 (IL-6)
interleukin-6 (IL-6), a pro-inflammatory cytokine produced by various cells in response to tissue injury, infection, or stress. IL-6 plays a key role in the acute-phase inflammatory response and is closely associated with the severity of systemic inflammation.
Click on the lead sponsor to view all of their trials.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Guangdong Provincial People's Hospital
Collaborator
Huai'an First People's Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
The First Affilated Hospital of the Medical College, Shihezi University
Collaborator
Xinhua Hospital of Ili Kazak Autonomous Prefecture
Collaborator
Henan Provincial Chest Hospital
Collaborator
