Efficacy of Sodium Oxybate to promote sleep in the ICU: A randomized controlled trial - Sodium oxybate to promote sleep in the IC

eiden University Medical Center0 个研究点目标入组 50 人开始时间: 2017年9月12日最近更新: 2024年4月8日

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•Use of sedatives for sleep problems, except 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 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.

发起方

eiden University Medical Center