LEDGIM trial

Recruiting

• Conditions: Postoperative delirium after gastrointestinal malignancy

• Registration Number: jRCTs041240116

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-30
• Study Start: 2024-11-11
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 260

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

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Occurrence of delirium	first week after the start of postoperative study drug administration	whether or not it occurs in the first week after the start of postoperative study drug administration