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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2022-07-31

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.

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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.

Conditions

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Sleep Deprivation Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Gabapentin

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.

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Gabapentin 100-300 mg is given to the intervention group

Standard care

Not receiving gabapentin.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gabapentin

Gabapentin 100-300 mg is given to the intervention group

Intervention Type DRUG

Other Intervention Names

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Gabapentin group

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No