JPRN-jRCTs041220161RecruitingPhase 3
The Study on the Effect of Acetaminophen on Postoperative Delirium in Orthopedic Surgery by its Analgesic Action
akashima Hiroaki0 sites300 target enrollmentStarted: April 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Over 18 years old
- •Patients undergoing orthopedic surgery under general anesthesia
- •The patient must understand the study and give written consent.
- •Patients must be able to maintain major organ function and meet all of the following criteria
- •(1) AST Less than 5 times the upper limit of the institutional reference value
- •(2) ALT Less than 5 times the upper limit of the institutional reference value
- •(3) Total bilirubin Less than 3 times the upper limit of the institutional reference value
- •(4) Creatinine Less than 3 times the upper limit of the institutional reference value
- •(5) No occurrence of events that, in the judgment of the investigator, would make it difficult to administer the study drug.
Exclusion Criteria
- •Symptoms of Grade 3 or higher (CTCAE v5.0) or abnormal laboratory values
- •Patients with a history of hypersensitivity or intolerance to acetaminophen or NSAIDs
- •Patients with a history of hypersensitivity or intolerance to acetaminophen or NSAIDs.
- •Patients with peptic ulcer.
- •Patients with serious blood disorders.
- •Patients with serious hepatic disorder.
- •Patients with serious renal failure.
- •Patients with serious cardiac dysfunction.
- •Patients with aspirin asthma (non-steroidal anti-inflammatory analgesics induced asthma attack) or a history of aspirin asthma.
- •Patients who are judged by the principal investigator to be unsuitable to participate in this study.
Investigators
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