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ID
Source
Brief title
Health condition
Sleep disruption in the ICU
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sleep efficiency during the designated ICU night period between 22:00 hrs and 06:00 hrs, as determined by polysomnography (PSG) on the second study night.
Secondary outcome
- total sleep time, sleep fragmentation index and total amount of slow wave sleep as determined by polysomnography on the second study night;
- total sleep time per night assessed by actigraphy;
- incidence of delirium;
- outcome parameters of patient- and nurse-derived sleep questionnaire scores (RCSQ).
Background summary
We aim to include 50 patients who are experiencing sleep disruption and will randomize these between two treatment arms: standard treatment (temazepam) versus SXB during three consecutive nights. Sleep scores will be obtained as well as polysomnography on the second study night in both groups. To study the quality of sleep in our ICU we already implemented subjective nurse driven sleep scoring. This facilitates recognition and quantification of the current problems regarding sleep in our patient.
Study objective
Sodium oxybate is better at improving sleep efficiency in ICU patients with sleep disruption than temazepam.
Study design
3 nights of study drug administration
Intervention
In this pilot study, a double-blind double-dummy design will be used. One group will receive standard care i.e. temazepam 1 x 20 mg at 22:00 hr and a placebo preparation of SXB at 22.00 hr and 02.00 hr. The other group will receive SXB 3.5 grams at 22.00 hr, and 3.5 gram at 02.00 hr (or 2 times 2,0 grams in case of a decreased liver function: spontaneously prolonged coagulation time or three times increased transaminase levels above the upper limit of normal), and a placebo preparation of temazepam at 22.00 hr. Upon study drug administration at 22.00 hr patients are asked to attempt to sleep.
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7983 |
| Other | METC LUMC : P17.221 |