Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Slow-wave sleep
研究概览
简要总结
The investigators proposed that gabapentin will increase slow-wave sleep in adult critically ill patients. Increasing slow-wave sleep will improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.
详细描述
Up to 61% of critically ill patients have sleep deprivation in ICU. Sleep deprivation can cause delirium and lead to prolonged ICU length of stay and mechanical ventilator days. However, pharmacologic interventions to improve sleep quality and prevent sleep deprivation are poorly tested for efficacy and safety in ICU patients. There were reports of gabapentin increasing slow-wave sleep in healthy populations and insomnia patients with insignificant adverse events. Therefore, gabapentin might increase slow-wave sleep resulting in improving clinical outcomes in adult critically ill patients. The objectives of the study were to evaluate the efficacy, especially on slow-wave sleep, and safety of gabapentin in adult critically ill patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years and older)
- •Patients admitted to ICU not more than 24 hours at the time of randomization
排除标准
- •Patients admitted to ICU less than 72 hours
- •Patients receiving gabapentin within 14 days prior to randomization
- •Patients receiving restorative drug (trazodone, mirtazapine, olanzapine, agomelatine, and pregabalin) within 7 days prior to randomization
- •Patients having contraindications to gabapentin
- •Patients receiving high dose vasopressors more than 1 hour during ICU admissions
- •Patients presenting with severe respiratory failure (PF ratio < 100)
- •Patients presenting with RASS < -2 at the time of randomization
- •Patients having target RASS of <-2 during ICU admissions
- •Terminal ill patients
- •Pregnancy
研究组 & 干预措施
Gabapentin
Start gabapentin 100 mg at 9.00 PM on the second night of ICU admission and titrate gabapentin dose as needed. Maximum gabapentin dose in this study is 300 mg/day.
干预措施: Gabapentin (Drug)
结局指标
主要结局
Slow-wave sleep
时间窗: at least 3 consecutive days after randomization
Slow-wave sleep period or deep sleep period
次要结局
- All-cause hospital mortality(During hospital stay or death or a maximum of 90 days)
- Incidence of self-extubation(During ICU stay or death or a maximum of 28 days)
- Incidence of sleep deprivation(During ICU stay or death or a maximum of 28 days)
- ICU free days(During ICU stay or death or a maximum of 28 days)
- Mechanical ventilator free days(During ICU stay or death or a maximum of 28 days)
- Hospital free days(During hospital stay or death or a maximum of 90 days)
- Delirium free day(During ICU stay or death or a maximum of 28 days)