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

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT04818450

Collaborator

(none)

Enrollment

Location

Arms

15.4

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Deprivation Critically Ill	Drug: Gabapentin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 19, 2021

Actual Primary Completion Date :

Jun 25, 2022

Actual Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Gabapentin Gabapentin 100-300 mg is given to the intervention group Other Names: Gabapentin group
No Intervention: Standard care Not receiving gabapentin.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Gabapentin

Gabapentin 100-300 mg is given to the intervention group

Other Names:

Gabapentin group

No Intervention: Standard care

Not receiving gabapentin.

Outcome Measures

Primary Outcome Measures

Slow-wave sleep [at least 3 consecutive days after randomization]
Slow-wave sleep period or deep sleep period

Secondary Outcome Measures

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

Other Outcome Measures

IGF-1 [At day 0, 1, 3, and 5 after randomization]
IGF-1 level

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ramathibodi Hospital, Mahidol University	Ratchathewi	Bangkok	Thailand	10400

Sponsors and Collaborators

Mahidol University

Investigators

Study Director: Yuda Sutherasan, MD, Ramathibodi hospital, Mahidol university
Principal Investigator: Kanyarat Susantitapong, B.Sc.(Pharm), Mahidol University
Study Director: Pitchaya Dilokpattanamongkol, BCPS, BCCCP, BCP, Mahidol University
Study Chair: Chuthamanee Suthisisang, Ph.D., Mahidol University
Study Chair: Viratch Tangsujaritvijit, Ph.D., Piyavate Hospital