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

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.

Full Title of Study: “Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 25, 2022

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.

Interventions

  • Drug: Gabapentin
    • Gabapentin 100-300 mg is given to the intervention group

Arms, Groups and Cohorts

  • 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.
  • No Intervention: Standard care
    • Not receiving gabapentin.

Clinical Trial Outcome Measures

Primary Measures

  • Slow-wave sleep
    • Time Frame: at least 3 consecutive days after randomization
    • Slow-wave sleep period or deep sleep period

Secondary Measures

  • All-cause hospital mortality
    • Time Frame: During hospital stay or death or a maximum of 90 days
    • Rates of all-cause mortality during hospital stay
  • ICU free days
    • Time Frame: During ICU stay or death or a maximum of 28 days
    • Days alive and not stay in ICU
  • Mechanical ventilator free days
    • Time Frame: During ICU stay or death or a maximum of 28 days
    • Day alive and free of mechanical ventilator
  • Hospital free days
    • Time Frame: During hospital stay or death or a maximum of 90 days
    • Days alive and not stay in hospital
  • Incidence of self-extubation
    • Time Frame: 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
    • Time Frame: During ICU stay or death or a maximum of 28 days
    • Times per patient-days of sleep deprivation during ICU stay
  • Delirium free day
    • Time Frame: During ICU stay or death or a maximum of 28 days
    • Days alive and not having delirium

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yuda Sutherasan, MD, Study Director, Ramathibodi hospital, Mahidol university
    • Kanyarat Susantitapong, B.Sc.(Pharm), Principal Investigator, Mahidol University
    • Pitchaya Dilokpattanamongkol, BCPS, BCCCP, BCP, Study Director, Mahidol University
    • Chuthamanee Suthisisang, Ph.D., Study Chair, Mahidol University
    • Viratch Tangsujaritvijit, Ph.D., Study Chair, Piyavate Hospital

References

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.

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.

Citations Reporting on Results

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.

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.

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.

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.

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.

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