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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041220114

Registered date:27/12/2022

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedHepatectomy or pancreatectomy for diseases of the liver, biliary tract, pancreas, and duodenum
Date of first enrollment13/01/2023
Target sample size82
Countries of recruitment
Study typeInterventional
Intervention(s)Proton pump inhibitor is administered from post-surgery to day 7

Outcome(s)

Primary OutcomeThe incidence of postoperative delirium evaluated by the Confusion Assessment Method-Intensive Care Unit(CAM-ICU) flow sheet
Secondary Outcome1.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 maximumNot applicable
GenderBoth
Include criteria1.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 criteria1.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

Contact

Public contact
Name Mihoko Yamada
Address 1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail mi.yamada@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Teiichi Sugiura
Address 1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail t.sugiura@scchr.jp
Affiliation Shizuoka Cancer Center