Evaluation of the efficacy of yokukansan for postoperative delirium

JRCT ID: jRCTs061180007

Registered date:29/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Postoperative delirium
• Date of first enrollment: 11/07/2017
• Target sample size: 140
• Study type: Interventional
• Intervention(s): From 2 days before surgery to 3 days after surgery,the subject will take Yokukansan or Anchusan after each meal.

Outcome(s)

• Primary Outcome: Incidence rate of delirium diagnosed using DSM-5 by psychiatrists on postoperative day 1,2, and 3

Secondary Outcome

Severity of delirium by Delirium Rating Scale R-98
Safety (adverse events, laboratory values, postoperative complications, postoperative mortality)

Key inclusion & exclusion criteria

• Age minimum: 75age
• Age maximum: Unlimited
• Gender: Both
• Include criteria: Patients who need surgery for gastrointestinal cancerPatients who can start oral administration early after surgery

Exclude criteria

Patients with past history of hypersensitivity to yokukansan or anchusan
Patients diagnosed with pseudoaldosteronism
Patients diagnosed with heart failure showing NYHA classification grade more than 3
Patients with a history of rhabdomyolysis
Patients diagnosed with interstitial pneumonia
Patients diagnosed with liver failure (AST,ALT>= or Total Bilirubin>=1.5)
Patients who cannot start oral administration early after surgery, such as esophageal cancer patients
Patients with mood disorder, schizophrenia, schizoaffective disorder, alcoholism, drug addiction
Patients determined to be unable to join the clinical trial

Related Information

• Primary Sponsor: Fujiwara Yoshiyuki
• Secondary ID(s): UMIN000027976