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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041200062

Registered date:10/11/2020

A phase II randomized trial of ramelteon on postoperative delirium in elderly gastric cancer patient

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedStomach cancer
Date of first enrollment05/02/2021
Target sample size210
Countries of recruitment
Study typeInterventional
Intervention(s)Taking ramelteon of 8 mg will be started 7 days before the operation. Ramelteon will be then resumed from the resume of drinking water and be continued until discharge.

Outcome(s)

Primary OutcomeThe incidence of postoperative delirium
Secondary OutcomePostoperative complication Adverse events related to ramelteon treatment

Key inclusion & exclusion criteria

Age minimum>= 75age old
Age maximumNot applicable
GenderBoth
Include criteria1) Histologically proven adenocarcinoma of the stomach (including special types of gastric cancer such as endocrine cell carcinoma (NEC), carcinoid tumors, and Siewert type II/III esophagogastric junction carcinoma.) 2) Planned radical gastrectomy other than local resection 3) Age>=75 years old 4) PS 0 or 1 5) Oral medication able to be ingested without bowel obstruction or bleeding 6) WBC >= 3,000 /mm3 PLT >= 100,000 /mm3 AST<=100 IU/L,ALT<=100 IU/L T-Bil<=2.0 mg/dl Cre<= 1.5 mg/dl 7)Written informed consent
Exclude criteria1) Dementia 2) Psychologic disorders (including habitual use of sleeping medicine, and alcoholism) 3) CAM-ICU not able to be performed 4) Habitual use of opioid or steroid (including inhalation, excluding ointment, nasal spray, eye-drops) 5) A history of hypersensitivity to ramelteon 6) Currently receiving fluvoxamine

Related Information

Contact

Public contact
Name Kenichiro Furukawa
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail ke.furukawa@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Masanori Terashima
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail m.terashima@scchr.jp
Affiliation Shizuoka Cancer Center