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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041200062
Enrollment
210
Registered
2020-11-10
Start date
2021-02-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach cancer

Interventions

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.

Sponsors

Terashima Masanori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative delirium

Secondary

MeasureTime frame
Postoperative complication Adverse events related to ramelteon treatment

Contacts

Public ContactKenichiro Furukawa

Shizuoka Cancer Center

ke.furukawa@scchr.jp+81-55-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026