NL-OMON25983
Recruiting
Not Applicable
Efficacy of Sodium Oxybate to promote sleep in the ICU: A randomized controlled trial
eiden University Medical Center0 sites50 target enrollmentTBD
ConditionsSleep disruption in the IC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep disruption in the IC
- Sponsor
- eiden University Medical Center
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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