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

Mahidol University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Sleep Deprivation Critically Ill

Interventions

GabapentinDRUG

Gabapentin 100-300 mg is given to the intervention group

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, Thailand

Outcomes

Primary Outcomes

Slow-wave sleep

Slow-wave sleep period or deep sleep period

Time frame: at least 3 consecutive days after randomization

Secondary Outcomes

All-cause hospital mortality

Rates of all-cause mortality during hospital stay

Time frame: During hospital stay or death or a maximum of 90 days

ICU free days

Days alive and not stay in ICU