Study on the preventive effect of ramelteon on the onset of sleep disorder after general anesthesia in patients with autism spectrum disorder: A study protocol
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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