Status:
UNKNOWN
Impact of Acetaminophen on Postoperative Delirium Elderly Patients After Non-cardiac Surgery
Lead Sponsor:
Xiangya Hospital of Central South University
Collaborating Sponsors:
Yale University
Conditions:
Acetaminophen
Delirium in Old Age
Eligibility:
All Genders
65+ years
Phase:
EARLY_PHASE1
Brief Summary
To investigate the impact of acetaminophen analgesia on the frequency of postoperative delirium and 28 days mortality in elderly patients after noncardiac surgery.
Detailed Description
Background: Delirium is a common complication following surgery contributes to adverse outcomes, including increased mortality and morbidity, longer length of ICU stays, prolonged mechanical ventilati...
Eligibility Criteria
Inclusion
- Scheduled to ICU after non-cardiac surgery for any reasons；
- Report having moderate to severe acute pain as determined by a pain score ≥ 5 from the 11-point Numeric Pain Rating Scale (NPRS) scale after postsurgery；
- Able to take oral medication or by stomach tube；
- Provide written informed consent.
Exclusion
- Patients who meet any of the following criteria will be excluded.
- Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
- Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
- Brain injury or neurosurgery;
- Severe hepatic dysfunction (eg, aspartate aminotransferase, alanine aminotransferase, or bilirubin greater than or equal to 3.0 times the upper limit of normal), active hepatic disease, evidence of clinically significant liver disease, or other condition (eg, alcoholism, cirrhosis, or hepatitis) that suggests the potential for an increased susceptibility to hepatic toxicity with study drug exposure.
- Subject has a positive test result for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methamphetamine, methadone, or methylenedioxy-methamphetamine) at Screening.
- Subject has participated in another clinical study within 30 days prior to day-of-surgery or plans to participate in another clinical study while concurrently enrolled in this study.
- Subject has a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen or morphine or to any of the excipients in the IV or oral formulations used.
- Subject has intra- or postoperative complications, which in the view of the investigator, makes the subject unsuitable for the participation of the study.
- Subject has a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen or opioid or to any of the excipients in the IV or oral formulations used.
- Unable to take medications orally or by stomach tube
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT03763084
Start Date
February 15 2019
End Date
November 1 2020
Last Update
March 8 2019
Active Locations (1)
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1
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410000