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

Not Applicable

Completed

• Conditions: Sleep Deprivation; Critically Ill
• Interventions: Drug: Gabapentin

• Registration Number: NCT04818450
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Study Start: 2021-04-19
• Primary Completion: 2022-06-25
• Study Completion: 2022-07-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	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.

Primary Outcome Measures

Name	Time	Method
Slow-wave sleep	at least 3 consecutive days after randomization	Slow-wave sleep period or deep sleep period

Secondary Outcome Measures

Name	Time	Method
All-cause hospital mortality	During hospital stay or death or a maximum of 90 days	Rates of all-cause mortality during hospital stay
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
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
Hospital free days	During hospital stay or death or a maximum of 90 days	Days alive and not stay in hospital
Delirium free day	During ICU stay or death or a maximum of 28 days	Days alive and not having delirium

Trial Locations

Locations (1)

Ramathibodi Hospital, Mahidol University; 🇹🇭 Ratchathewi, Bangkok, Thailand