Efficacy of Sodium Oxybate to promote sleep in the ICU: A randomized controlled trial
- Conditions
- Sleep disruption in the IC
- Registration Number
- NL-OMON25983
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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.
Use of sedatives for sleep problems (for example benzodiazepine use) in the last 3 days, except a low dose of Sufentanil (up to 2,5 µg/hr) in intubated patients since this dose is frequently needed to counteract laryngeal tube irritation;
Current use of haloperidol, except a maintenance dose in patients recovering from a delirium;
RASS score < -2;
Active delirium, as assessed by a ICDSC-NL score > 3;
SSADH-deficiency;
Severe depression;
Planned ICU admission time < 3 nights after detection of sleep difficulties.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method