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

JRCT ID: jRCTs041200062

Registered date:10/11/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stomach cancer
• Date of first enrollment: 05/02/2021
• Target sample size: 210
• Study type: Interventional
• 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 Outcome: The incidence of postoperative delirium

Secondary Outcome

Postoperative complication
Adverse events related to ramelteon treatment

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Terashima Masanori