Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653465
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-20
Brief Title:
Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery a Randomised Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We propose this multi-center randomised controlled study to test the preventive effect of intravenouse acetaminophen in delirium over 5 postoperative days among older patients recovering from major non-cardiac surgery
Detailed Description:
Delirium is a common complication in elderly patients after major surgeries and can lead to poor outcomes such as neurocognitive decline Acetaminophen is a widely used adjuvant for perioperative multimodal analgesia It can effectively alleviate postoperative pain promote opioid-sparing and exert anti-neuroinflammatory response showing strong potential for preventing postoperative delirium There is evidence that intravenous acetaminophen reduces delirium in older patients following cardiac surgery but its effectiveness is inconclusive among non-cardiac surgical patients We propose a multi-center randomized placebo-controlled parallel-group trial in patients aged 65 years old scheduled for non-cardiac major surgery with general anesthesia expected to last at least 2 h A total of 1930 elderly patients will be enrolled and randomized at 11 ratio to acetaminophen or saline placebo groups stratified by age education level and trial site with random-sized blocking Acetaminophen or saline will be given when the surgical suture begin at the end of surgery and thereafter a total of 7 doses within 48h after surgery Our primary outcome will be the incidence of delirium assessed twice daily through the five postoperative days Secondary outcomes will include pain scores with movement opioid use within the first 48 postoperative hours severity of delirium ICU and hospital lengths of stay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None