The Study on the Effect of Acetaminophen on Postoperative Delirium in Orthopedic Surgery by its Analgesic Actio

Phase 3

Recruiting

• Conditions: orthopedic disease; Orthopedic surgery; D009985

• Registration Number: JPRN-jRCTs041220161
• Lead Sponsor: akashima Hiroaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of delirium according to CAM Japanese version

Secondary Outcome Measures

Name	Time	Method
Postoperative pain VAS (6, 24, 48 hours, 3, 7 days postoperatively)<br>Therapeutic acetaminophen administration up to 48 hours postoperatively for acetaminophen non-treatment group<br>Total opioid dose during hospitalization<br>Time from postoperative to discharge<br>Presence of psychiatric intervention at the time of delirium