Critically Ill, Sleep Deprivation
Conditions
Keywords
gabapentin, sleep deprivation, critically ill patients, slow-wave sleep
Brief summary
The investigators proposed that gabapentin will increase slow-wave sleep in adult critically ill patients. Increasing slow-wave sleep will improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.
Detailed description
Up to 61% of critically ill patients have sleep deprivation in ICU. Sleep deprivation can cause delirium and lead to prolonged ICU length of stay and mechanical ventilator days. However, pharmacologic interventions to improve sleep quality and prevent sleep deprivation are poorly tested for efficacy and safety in ICU patients. There were reports of gabapentin increasing slow-wave sleep in healthy populations and insomnia patients with insignificant adverse events. Therefore, gabapentin might increase slow-wave sleep resulting in improving clinical outcomes in adult critically ill patients. The objectives of the study were to evaluate the efficacy, especially on slow-wave sleep, and safety of gabapentin in adult critically ill patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand.
Interventions
DRUGGabapentin
Gabapentin 100-300 mg is given to the intervention group
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (18 years and older) * Patients admitted to ICU not more than 24 hours at the time of randomization
Exclusion criteria
* Patients admitted to ICU less than 72 hours * Patients receiving gabapentin within 14 days prior to randomization * Patients receiving restorative drug (trazodone, mirtazapine, olanzapine, agomelatine, and pregabalin) within 7 days prior to randomization * Patients having contraindications to gabapentin * Patients receiving high dose vasopressors more than 1 hour during ICU admissions * Patients presenting with severe respiratory failure (PF ratio \< 100) * Patients presenting with RASS \< -2 at the time of randomization * Patients having target RASS of \<-2 during ICU admissions * Terminal ill patients * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slow-wave sleep | at least 3 consecutive days after randomization | Slow-wave sleep period or deep sleep period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause hospital mortality | During hospital stay or death or a maximum of 90 days | Rates of all-cause mortality during hospital stay |
| ICU free days | During ICU stay or death or a maximum of 28 days | Days alive and not stay in ICU |
| Mechanical ventilator free days | During ICU stay or death or a maximum of 28 days | Day alive and free of mechanical ventilator |
| Incidence of self-extubation | During ICU stay or death or a maximum of 28 days | Number of patients who had self-extubation during ICU stay |
| Incidence of sleep deprivation | During ICU stay or death or a maximum of 28 days | Times per patient-days of sleep deprivation during ICU stay |
| Delirium free day | During ICU stay or death or a maximum of 28 days | Days alive and not having delirium |
| Hospital free days | During hospital stay or death or a maximum of 90 days | Days alive and not stay in hospital |
Other
| Measure | Time frame | Description |
|---|---|---|
| IGF-1 | At day 0, 1, 3, and 5 after randomization | IGF-1 level |
Countries
Thailand
Outcome results
None listed