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A multicenter phase II randomized trial of ramelteon on prevention of postoperative delirium after gastrectomy in elderly patient

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

Terashima Masanori

Shizuoka Cancer Center

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

m.terashima@scchr.jp

Furukawa Kenichiro

Shizuoka Cancer Center

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

+81-55-989-5222

ke.furukawa@scchr.jp

Recruiting

Feb. 01, 2021

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1) 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

1) 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

Both

Stomach cancer

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.

The incidence of postoperative delirium

Postoperative complication
Adverse events related to ramelteon treatment

+81-559895222

Oct. 27, 2020

No

none