Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.

Conditions
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Sleep Deprivation, Critically Ill

Intervention / Treatment
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* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Start gabapentin 100 mg at 9.00 PM on the second night of ICU admission and titrate gabapentin dose as needed. Maximum gabapentin dose in this study is 300 mg/day. | Drug: Gabapentin<br>* Gabapentin 100-300 mg is given to the intervention group<br>* Other names: Gabapentin group;|
| No Intervention: Standard care<br>Not receiving gabapentin. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slow-wave sleep | Slow-wave sleep period or deep sleep period | at least 3 consecutive days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause hospital mortality | Rates of all-cause mortality during hospital stay | During hospital stay or death or a maximum of 90 days | 
| ICU free days | Days alive and not stay in ICU | During ICU stay or death or a maximum of 28 days | 
| Mechanical ventilator free days | Day alive and free of mechanical ventilator | During ICU stay or death or a maximum of 28 days | 
| Hospital free days | Days alive and not stay in hospital | During hospital stay or death or a maximum of 90 days | 
| Incidence of self-extubation | Number of patients who had self-extubation during ICU stay | During ICU stay or death or a maximum of 28 days | 
| Incidence of sleep deprivation | Times per patient-days of sleep deprivation during ICU stay | During ICU stay or death or a maximum of 28 days | 
| Delirium free day | Days alive and not having delirium | During ICU stay or death or a maximum of 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gabapentin, sleep deprivation, critically ill patients, slow-wave sleep