JPRN-jRCTs031210673
Recruiting
Phase 3
Ramelteon for prevention of postoperative delirium in delirium high-risk cancer patients.: A randomized, double-blind, placebo-controlled multi-center trial, JORTC-PON02/J-SUPPORT2103/NCCH2103. - RAMP trial
Matsuoka Hiromichi0 sites766 target enrollmentApril 1, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Delirium
- Sponsor
- Matsuoka Hiromichi
- Enrollment
- 766
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Pathologically confirmed and/or clinically suspected malignant tumor
- •2\) Aged 65 or older at enrollment
- •3\) Undergoing surgery under general anesthesia and postoperative hospitalization for 5 days or over
- •4\) Preoperative ability to take medication orally or via nasogastric tube and postoperative plan to take medication orally or via nausal gastric tube from postoperative day 2 or earlier.
- •5\) Written informed consent from patient or written informed consent from witness, who is not working in the present study, with patient's oral consent.
Exclusion Criteria
- •1\) Diagnosed as delirium with DSM\-5 at enrollment
- •2\) Allergy to ramelteon
- •3\) Sevea liver dysfunction according to criteria of total bil \> 2\.25 mg/dL, AST \> 90 U/L, ALT \> 126 U/L for male, or ALT \> 69 U/L for female
- •4\) History of participation to clinical trials within 4 weeks including a day of enrollment except for the completed protocol treatment and in the observation period
- •5\) History of medication of ramelteon or flurvoxamine within 2 weeks including a day of enrollment
- •6\) History of medication of suvorexant or lemborexant 2 weeks including a day of enrollment
- •7\) History of epilepsy, Parkinson's dosease, or dementia with lewy bodies
- •8\) Lactose intolerance
- •9\) Planned surgical procesure including central nervous system or intracranial region.
- •10\) History of drug or alcohol use disorder or daily alcohol intake over 60g or alcohol\-related disease within 5 years including a day of enrollment
Outcomes
Primary Outcomes
Not specified
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