臨床研究等提出・公開システム

A randomized controlled phase II study of lemborexant for preventing delirium after gastrointestinal malignant tumor surgery

LEDGIM trial

Takeuchi Hiroya

Hamamatsu University Hospital

1-20-1 Handayama, Cyuou-ku, Hamamatsu city, Shizuoka

takeuchi@hama-med.ac.jp

Sakai Yuki

Hamamatsu University Hospital

1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka

+81-53-435-2111

yongqijingjing@gmail.com

Recruiting

Oct. 30, 2024

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

prevention purpose

1) Patients with a clinical diagnosis of gastrointestinal malignancy
2) Patients over 40 years old
3) Patients with PS (ECOG) of 0 or 1
4) AST100 IU/L, ALT=<100IU/L
5) Total bilirubin=<2.0 mg/dl
6) Serum creatinine =<1.5 mg/dl
7) Patients who have given written consent to participate in the study.

1) Persons diagnosed with dementia
2) Patients with mental illness (including alcoholism)
3) Patients with a history of regular use of sleeping pills (both BZ and non-BZ drugs)
4) Patients with a history of hypersensitivity to Lenvorexant, Ramelteon, Mianserin, or Trazodone
5) Patients taking drugs contraindicated with Lenvorexant, Ramelteon, Mianserin, or Trazodone.
6) Other subjects who are deemed inappropriate to participate in this study by the principal investigator and subinvestigators.

Both

Postoperative delirium after gastrointestinal malignancy

The day of surgery is set as Day 0, and the study medication is started on Day 1 (+2 days).
Group A: Ramelteon 8 mg once before bedtime (just before bedtime).
Group B: 8 mg of ramelteon once a day before bedtime (just before bedtime) and 5 mg of lenvorexant once a day just before bedtime.

Occurrence of delirium (whether or not it occurs in the first week after the start of postoperative study drug administration)

1. number of awakenings
2. duration of mid-wake
3. sleep assessment by RCSQ
4. postoperative complications
5. postoperative hospital stay
6. Adverse events

+81-53-435-2680

Oct. 23, 2024

No

none