Postoperative delirium after gastrointestinal malignancy
Conditions
Interventions
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 bef
Sponsors
Takeuchi Hiroya
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of delirium (whether or not it occurs in the first week after the start of postoperative study drug administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. number of awakenings 2. duration of mid-wake 3. sleep assessment by RCSQ 4. postoperative complications 5. postoperative hospital stay 6. Adverse events | — |
Contacts
Public ContactYuki Sakai
Hamamatsu University Hospital
Outcome results
None listed