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

Mahidol University

Status: Completed

Conditions: Critically Ill; Sleep Deprivation

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT04818450

MURA2021/170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Gabapentin

Experimental group

Description:

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.

Treatment:

Drug: Gabapentin

Standard care

No Intervention group

Description:

Not receiving gabapentin.