Esophageal cancer
Conditions
Interventions
Taking ramelteon of 8 mg will be started 7 days before the operation. Taking suvorexant of 15 mg will be started the day before the operation. Ramelteon and suvorexant will be then resumed from the da
Sponsors
Tsubosa Yasuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven esophageal cancer 2) Planned radical esophagectomy 3) Age>=60 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) Habitual use of psychotropic drug use 3) Uncontrolled diabetes 4) CAM-ICU not able to be performed 5) Habitual use of opioid or steroid 6) A history of hypersensitivity to ramelteon 7) Habitual use of drugs that inhibit or induce CYP3A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of postoperative delirium (CAM-ICU) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Incidence of delirium based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (2) Incidence hyperactive delirium (3) Duration of delirium (4) Treatment of delirium (5) Intraoperative complications (6) Postoperative complication (7) Adverse events associated with ramelteon and suvorexant (8) Postoperative hospital stay | — |
Contacts
Public ContactSyuhei Mayanagi
Shizuoka Cancer Center
Outcome results
None listed