NL-OMON56249招募中2 期
Efficacy of Sodium Oxybate to promote sleep in the ICU: A randomized controlled trial - Sodium oxybate to promote sleep in the IC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Admission to the ICU/MCU;
- •Expected duration of ICU/MCU admission > 2 nights after detection of sleep
- •difficulties ;
- •Awake, conscious (patients can be intubated);
- •RASS (Richmond Agitation-Sedation Scale) score >= -2;
- •The patient is experiencing sleep difficulties based on their own or clinical
- •judgment as well as on a low score (<60% average score) on the Richard Campbell
- •Sleep Questionnaire;
- •The ICU physician intends to prescribe general sleep promoting measures as well
- •as a benzodiazepine because of the sleep problems.
排除标准
- •Use of sedatives (dexmedetomidine, temazepam, oxazepam, propofol, midazolam)
- •for sleep problems except for a low dose of sufentanil (up to 5 µg/hr) in
- •intubated patients since this dose is frequently needed to counteract laryngeal
- •tube irritation;
- •Use of certain medication before inclusion:
- •- More than 1 night of temazepam use: 1 night washout before inclusion;
- •- Propofol: 1 night washout before inclusion;
- •- Midazolam: 2 nights washout before inclusion.
- •Current use of haloperidol, except a maintenance dose in patients recovering
- •from a delirium;
- •RASS score < -2;
- •Active delirium, as assessed by the ICDSC-NL score;
- •SSADH-deficiency;
- •Severe depression;
- •Planned ICU admission time < 3 nights after detection of sleep difficulties.
研究者
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