Study on the preventive effect of ramelteon on the onset of sleep disorder after general anesthesia in patients with autism spectrum disorder

Ayuse Takao0 个研究点目标入组 90 人开始时间: 2020年9月11日最近更新: 2023年10月17日

适应症

试验速览

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•1)Age: Autism spectrum disorder patient who is between 12 years old and 60 years old at the time of obtaining consent
•2)Patients who fullfill next criteria, 1: Patients who have already been diagnosed with insomnia and have been given oral treatment with drugs other than Rozerem. 2: Patients who have not been diagnosed with sleep disorders in the past, but are probable insomnia with a score of 4 to 5 on the Athens insomnia scale or probable insomnia with a score of 6 or more before admission to the hospital.
•3)Patients without serious systemic complications (ASA PS I-II)
•4)Gender: Any
•5)Hospitalization/Outpatient: Hospitalization only
•6)Patient's parents who, after receiving a sufficient explanation to participate in this study, gained a thorough understanding and obtained the informed consent of their parents.

•1)Patients already taking Rozerem
•2)Lactating women
•3)Patients with serious complications (ASA PSIII or higher)
•4)Patients with a history of hypersensitivity to Rozerem
•5)Patients with advanced liver dysfunction
•6)Patients receiving fluvoxamine maleate
•7)Other patients that the investigator judged to be inappropriate as the study subjects

发起方

Ayuse Takao