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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041220161

Registered date:01/04/2023

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedorthopedic disease
Date of first enrollment01/04/2023
Target sample size300
Countries of recruitment
Study typeInterventional
Intervention(s)For the acetaminophen treated group, acetaminophen is administered as a postoperative analgesic at a dose of 1000 mg intravenously over 15 minutes at the time of wound closure for patients weighing 50 kg or more. Thereafter, it is administered every 6 hours starting 6 hours after the end of surgery. A total of 9 doses are administered (at the time of wound closure and 6, 12, 18, 24, 30, 36, 42, and 48 hours after the end of surgery). For patients weighing less than 50 kg, 15 mg per kg of body weight is administered intravenously over 15 minutes at the time of wound closure. Thereafter, the dose is administered every 6 hours starting 6 hours after the end of surgery. A total of 9 doses (at wound closure and 6, 12, 18, 24, 30, 36, 42, and 48 hours after the end of surgery). Acetaminophen is not routinely administered to the acetaminophen non-treated patients.

Outcome(s)

Primary OutcomeIncidence of delirium according to CAM Japanese version
Secondary OutcomePostoperative pain VAS (6, 24, 48 hours, 3, 7 days postoperatively) Therapeutic acetaminophen administration up to 48 hours postoperatively for acetaminophen non-treatment group Total opioid dose during hospitalization Time from postoperative to discharge Presence of psychiatric intervention at the time of delirium

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaOver 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.
Exclude criteriaSymptoms 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.

Related Information

Contact

Public contact
Name Sadayuki Ito
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan Aichi Japan 466-8560
Telephone +81-52-741-2111
E-mail sadaito@med.nagoya-u.ac.jp
Affiliation Orthopedic Surgery
Scientific contact
Name Hiroaki Nakashima
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan Aichi Japan 466-8560
Telephone +81-52-741-2111
E-mail hirospine@med.nagoya-u.ac.jp
Affiliation Orthopedic Surgery