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 个研究点目标入组 766 人开始时间: 2022年4月1日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•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.

•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
•11) History of participation to the present study
•12) Comorbidity of moderate to severe dementia according to MMSE-J < 21
•13) Severe visual or auditory handicap, or illiteracy
•14) ECOG PS 4 at enrolment
•15) Judgement as inadequate by principal investigator or other investigators

发起方

Matsuoka Hiromichi