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

Primary Purpose

Sleep Deprivation, Critically Ill

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Deprivation focused on measuring gabapentin, sleep deprivation, critically ill patients, slow-wave sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ramathibodi Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gabapentin

Standard care

Arm 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.

Not receiving gabapentin.

Outcomes

Primary Outcome Measures

Slow-wave sleep
Slow-wave sleep period or deep sleep period

Secondary Outcome Measures

All-cause hospital mortality
Rates of all-cause mortality during hospital stay
ICU free days
Days alive and not stay in ICU
Mechanical ventilator free days
Day alive and free of mechanical ventilator
Hospital free days
Days alive and not stay in hospital
Incidence of self-extubation
Number of patients who had self-extubation during ICU stay
Incidence of sleep deprivation
Times per patient-days of sleep deprivation during ICU stay
Delirium free day
Days alive and not having delirium

Full Information

First Posted
March 25, 2021
Last Updated
August 10, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04818450
Brief Title
Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient
Acronym
GASWAC
Official Title
Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
June 25, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Critically Ill
Keywords
gabapentin, sleep deprivation, critically ill patients, slow-wave sleep

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm 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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Not receiving gabapentin.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Gabapentin group
Intervention Description
Gabapentin 100-300 mg is given to the intervention group
Primary Outcome Measure Information:
Title
Slow-wave sleep
Description
Slow-wave sleep period or deep sleep period
Time Frame
at least 3 consecutive days after randomization
Secondary Outcome Measure Information:
Title
All-cause hospital mortality
Description
Rates of all-cause mortality during hospital stay
Time Frame
During hospital stay or death or a maximum of 90 days
Title
ICU free days
Description
Days alive and not stay in ICU
Time Frame
During ICU stay or death or a maximum of 28 days
Title
Mechanical ventilator free days
Description
Day alive and free of mechanical ventilator
Time Frame
During ICU stay or death or a maximum of 28 days
Title
Hospital free days
Description
Days alive and not stay in hospital
Time Frame
During hospital stay or death or a maximum of 90 days
Title
Incidence of self-extubation
Description
Number of patients who had self-extubation during ICU stay
Time Frame
During ICU stay or death or a maximum of 28 days
Title
Incidence of sleep deprivation
Description
Times per patient-days of sleep deprivation during ICU stay
Time Frame
During ICU stay or death or a maximum of 28 days
Title
Delirium free day
Description
Days alive and not having delirium
Time Frame
During ICU stay or death or a maximum of 28 days
Other Pre-specified Outcome Measures:
Title
IGF-1
Description
IGF-1 level
Time Frame
At day 0, 1, 3, and 5 after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuda Sutherasan, MD
Organizational Affiliation
Ramathibodi hospital, Mahidol university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kanyarat Susantitapong, B.Sc.(Pharm)
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pitchaya Dilokpattanamongkol, BCPS, BCCCP, BCP
Organizational Affiliation
Mahidol University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chuthamanee Suthisisang, Ph.D.
Organizational Affiliation
Mahidol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Viratch Tangsujaritvijit, Ph.D.
Organizational Affiliation
Piyavate Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ramathibodi Hospital, Mahidol University
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30113379
Citation
Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
Results Reference
background
PubMed Identifier
32148342
Citation
Arttawejkul P, Reutrakul S, Muntham D, Chirakalwasan N. Effect of Nighttime Earplugs and Eye Masks on Sleep Quality in Intensive Care Unit Patients. Indian J Crit Care Med. 2020 Jan;24(1):6-10. doi: 10.5005/jp-journals-10071-23321.
Results Reference
background
PubMed Identifier
29605589
Citation
Carrera-Hernandez L, Aizpitarte-Pejenaute E, Zugazagoitia-Ciarrusta N, Goni-Viguria R. Patients' perceptions of sleep in a Critical Care Unit. Enferm Intensiva (Engl Ed). 2018 Apr-Jun;29(2):53-63. doi: 10.1016/j.enfi.2018.01.002. Epub 2018 Mar 28. English, Spanish.
Results Reference
result
PubMed Identifier
12460250
Citation
Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH. Gabapentin increases slow-wave sleep in normal adults. Epilepsia. 2002 Dec;43(12):1493-7. doi: 10.1046/j.1528-1157.2002.21002.x.
Results Reference
result
PubMed Identifier
28769860
Citation
Liu GJ, Karim MR, Xu LL, Wang SL, Yang C, Ding L, Wang YF. Efficacy and Tolerability of Gabapentin in Adults with Sleep Disturbance in Medical Illness: A Systematic Review and Meta-analysis. Front Neurol. 2017 Jul 14;8:316. doi: 10.3389/fneur.2017.00316. eCollection 2017.
Results Reference
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PubMed Identifier
25317090
Citation
Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1093-100. doi: 10.5664/jcsm.4108.
Results Reference
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PubMed Identifier
20124884
Citation
Lo HS, Yang CM, Lo HG, Lee CY, Ting H, Tzang BS. Treatment effects of gabapentin for primary insomnia. Clin Neuropharmacol. 2010 Mar-Apr;33(2):84-90. doi: 10.1097/WNF.0b013e3181cda242.
Results Reference
result

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

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