Evaluation of the efficacy of proton pump inhibitor for postoperative delirium after hepatobiliary and pancreatic surgery

JRCT ID: jRCTs041220114

Registered date:27/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatectomy or pancreatectomy for diseases of the liver, biliary tract, pancreas, and duodenum
• Date of first enrollment: 13/01/2023
• Target sample size: 82
• Study type: Interventional
• Intervention(s): Proton pump inhibitor is administered from post-surgery to day 7

Outcome(s)

• Primary Outcome: The incidence of postoperative delirium evaluated by the Confusion Assessment Method-Intensive Care Unit(CAM-ICU) flow sheet

Secondary Outcome

1.The incidence of delirium diagnosed by a psychiatrist based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
2.Duration of delirium
3.Treatment for delirium
4.The incidence of delirium according to the surgical procedure
5.The incidence of postoperative complication
6.The incidence of peptic ulcer
7.The incidence of adverse events related to proton pump inhibitor
8.Duration of the postoperative hospital stay

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients scheduled for elective hepatectomy or pancreatectomy for liver, biliary, pancreatic, and duodenal diseases
2.Age >= 70 years
3.Eastern Cooperative Oncology Group performance status of 0 or 1
4.Ability to undergo the Confusion Assessment Method-Intensive Care Unit (CAM-ICU)
5.Written informed consent

Exclude criteria

1.Patients scheduled for laparoscopic surgery.
2.Patients scheduled for hepatectomy combined with pancreatectomy.
3.Patients with dementia
4.Patients with a history of delirium
5.Patients diagnosed with psychological disorders such as alcoholism
6.Patients with habitual use of benzodiazepine receptor agonitst
7.Patients with habitual use of histamine H2-receptor antagonists within a week before registration
8.Patients with a history of hypersensitivity to proton pump inhibitor
9.Patients with habitual use of opioids or steroids
10.Patients who are determined not applicable for the study by the physician

Related Information

• Primary Sponsor: Sugiura Teiichi