LEDGIM trial

JRCT ID: jRCTs041240116

Registered date:30/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Postoperative delirium after gastrointestinal malignancy
• Date of first enrollment: 11/11/2024
• Target sample size: 260
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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 g/dl
6) Serum creatinine =<1.5 mg/dl
7) Patients who have given written consent to participate in the study.

Exclude criteria

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.

Related Information

• Primary Sponsor: Takeuchi Hiroya
• Source(s) of Monetary Support: Hamamatsu University School of Medicine