BACKGROUND: The persistent loss of consciousness caused by general anesthesia without the existence of repeated 90-minute cycles of non-REM and REM sleep might significantly disturb and suppress the cycle of normal physiological sleep in postoperative periods after general
anesthesia. Patients with autism spectrum disorders (ASD) with existing circadian rhythm disorder are reported to rapidly deteriorate due to acute sleep disorder during the perioperative period after general anesthesia.A melatonin receptor agonist, ramelteon (Rozerem), which is a sleep cycle regulator, is used as a therapeutic drug for patients with sleep disorders, but there are no studies
on the prevention of postoperative sleep disorder after general anesthesia.In this study, we investigate whether prophylactic
administration of a sleep-inducing substance, a melatonin receptor agonist, is effective against sleep disorder after general anesthesia in patients with ASD. METHODS/DESIGN: This study is intended for patients with ASD aged 12 years and above who undergo treatment at Nagasaki University Hospital, Isahaya General Hospital Dentistry, and Sasebo City General Medical Center Dentistry and undergo dental treatment under general anesthesia. A melatonin receptor agonist (Rozerem) will be taken 7 days prior and 7 days postsurgery
in patients diagnosed with insomnia. A randomized comparison will be made between 2 groups: an experimental group that is additionally administered Rozerem and a control group.The primary endpoint is the incidence of NREM-REM sleep disorders that occur within 3 to 5 days after general anesthesia. The secondary endpoint is the incidence of circadian rhythm sleep disorders (rate of occurrence of
sleep-retardation syndrome with drowsiness and strong fatigue). DISCUSSION: Postoperative sleep disorders after general anesthesia has been reported in patients with ASD; however, effective preventive pharmacological treatments have not been established. A sleep cycle regulator, ramelteon (Rozerem), is used as a therapeutic drug for patients with sleep disorders by decreasing the difficulty of falling asleep in insomnia. If sleep disorder can be prevented after the administration of general anesthesia
in patients with ASD, we can support social participation while maintaining their quality of life. TRIAL REGISTRATION: The study was registered with the jRCT1071200030.
雑誌名
Medicine
巻
99
号
43
ページ
e22826
発行年
2020-10-23
出版者
Wolters Klwer Health, Inc.
ISSN
00257974
EISSN
15365964
DOI
10.1097/MD.0000000000022826
権利
c 2020 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Study on the preventive effect of ramelteon on the onset of sleep disorder after general anesthesia in patients with autism spectrum disorder
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