A phase II randomized trial of ramelteon on postoperative delirium in elderly gastric cancer patient
Phase 2
Recruiting
- Conditions
- Stomach cancer
- Registration Number
- JPRN-jRCTs041200062
- Lead Sponsor
- Terashima Masanori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
1) Histologically proven adenocarcinoma of the stomach
2) Planned radical gastrectomy other than local resection
3) Age>=75 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) Psychologic disorders (including habitual use of sleeping medicine, and alcoholism)
3) CAM-ICU not able to be performed
4) Habitual use of opioid or steroid (excluding ointment, nasal spray, eye-drops)
5) A history of hypersensitivity to ramelteon
6) Currently receiving fluvoxamine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of postoperative delirium
- Secondary Outcome Measures
Name Time Method Postoperative complication<br>Adverse events related to ramelteon treatment