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临床试验/NL-OMON56249
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

eids Universitair Medisch Centrum0 个研究点目标入组 38 人开始时间: 待定最近更新:

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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