Sodium oxybate is better at improving sleep efficiency in ICU patients with sleep disruption than temazepam.
ID
Bron
Verkorte titel
Aandoening
Sleep disruption in the ICU
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Sodium oxybate is better at improving sleep efficiency in ICU patients with sleep disruption than temazepam.
Onderzoeksopzet
3 nights of study drug administration
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7983 |
| Ander register | METC LUMC : P17.221 |