術後睡眠障害に対するスボレキサントの有効性

実験的：Suvorexant administration

Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).

薬：スボレキサント

Suvorexant (Belsomra™) はオレキシン受容体拮抗薬で、開始用量 20mg で 2 錠 (各 10mg) として投与されます。 用量が十分に許容されない場合 (例えば、日中の眠気)、用量を 10 mg のスボレキサントに減らすことができます。

他の名前：

• ベルソムラ

プラセボコンパレーター：Placebo administration

Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 4 days).

薬：プラセボ

プラセボ錠剤はスボレキサントと同じ外観で、2 錠として服用します。

Total Sleep Time on Day 0 (TST)

Longitudinal Trend of TST

The longitudinal trend of TST over the four days will be measured using mixed-effect regression. Group, time (day 0-4), and group x time will be included as the fixed effects and a random intercept of subjects to account for within-subject correlation due to repeated measurement. Regression estimates will be reported.

Rate of Attrition

The rate of attrition over the 4 days will be measured. If any specific patterns are identified, inverse propensity treatment weighting will be performed to adjust the effect of nonrandom dropout.

Richards Campbell Self-Report Sleep Scale

The Richards Campbell self-report sleep scale will be used to determine the quality of sleep each morning. This five-item, visual analogue scale was designed as an outcome measure for assessing the perception of sleep. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality. For each item, respondents are given a visual analogue scale and are asked to place a mark on the line indicating where their own experiences fit between two extremes (for example, the degree to which they received a "good night's sleep" or "a bad night's sleep"). Scale lines extend from 0 to 100 mm, and scores are calculated by measuring where responses fall on each line. A total score is obtained by summing each score out of 100 and dividing the total by five. Lower scores indicate a poorer quality of sleep (worse outcome).

Number of Participants With Incidence of Delirium

The 3-minute diagnostic interview for Confusion Assessment Method (CAM)-defined delirium (3D-CAM) is a brief verbal assessment tool that can be used to test for delirium. For all items, if the subject's answer is 'incorrect', 'yes', 'don't know', 'no response', or 'non-sensical response', then the appropriate (unshaded) column on the right side is checked. Each of the 4 columns designates a CAM feature. If any one box in a column is checked, the feature is considered present. The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness.

Sleep Rescue Medication

Number of rescue medication divided by the nummber of days stayed. Given the fact that sleep medication is taken only once, this outcome measures the sleep rescue medications per day