Delirium Prevention Study
Phase 2
Recruiting
- Conditions
- Esophageal cancer
- Registration Number
- JPRN-jRCTs041220147
- Lead Sponsor
- Tsubosa Yasuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 43
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of postoperative delirium (CAM-ICU)
- Secondary Outcome Measures
Name Time Method (1) Incidence of delirium based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)<br>(2) Incidence hyperactive delirium<br>(3) Duration of delirium<br>(4) Treatment of delirium<br>(5) Intraoperative complications<br>(6) Postoperative complication <br>(7) Adverse events associated with ramelteon and suvorexant<br>(8) Postoperative hospital stay