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

NCT04818450 | Completed

• 1 other identifier: MURA2021/170
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation; Critically Ill

Keywords

gabapentin; sleep deprivation; critically ill patients; slow-wave sleep

Outcome Measures

Primary Outcomes (1)

• Slow-wave sleep

  Slow-wave sleep period or deep sleep period

  at least 3 consecutive days after randomization

Secondary Outcomes (7)

• All-cause hospital mortality

  During hospital stay or death or a maximum of 90 days

• ICU free days

  During ICU stay or death or a maximum of 28 days

• Mechanical ventilator free days

  During ICU stay or death or a maximum of 28 days

• Hospital free days

  During hospital stay or death or a maximum of 90 days

• Incidence of self-extubation

  During ICU stay or death or a maximum of 28 days

Other Outcomes (1)

• IGF-1

  At day 0, 1, 3, and 5 after randomization

Study Arms (2)

Gabapentin

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Not receiving gabapentin.

Interventions

Gabapentin DRUG

Gabapentin 100-300 mg is given to the intervention group

Also known as: Gabapentin group

Gabapentin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years and older)
• Patients admitted to ICU not more than 24 hours at the time of randomization

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (8)

• 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.

  PMID: 30113379 BACKGROUND

• 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.

  PMID: 32148342 BACKGROUND

• 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.

  PMID: 29605589 RESULT

• 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.

  PMID: 12460250 RESULT

• 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.

  PMID: 28769860 RESULT

• 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.

  PMID: 25317090 RESULT

• 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.

  PMID: 20124884 RESULT

• Susantitapong K, Dilokpattanamongkol P, Sutherasan Y, Liamsombut S, Suthisisang C. Effects of gabapentin on slow-wave sleep period in critically ill adult patients: A randomized controlled trial. Clin Transl Sci. 2024 May;17(5):e13815. doi: 10.1111/cts.13815.

  PMID: 38803031 DERIVED

MeSH Terms

Conditions

Sleep Deprivation; Critical Illness

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yuda Sutherasan, MD

  Ramathibodi hospital, Mahidol university

  STUDY DIRECTOR

• Kanyarat Susantitapong, B.Sc.(Pharm)

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Pitchaya Dilokpattanamongkol, BCPS, BCCCP, BCP

  Mahidol University

  STUDY DIRECTOR

• Chuthamanee Suthisisang, Ph.D.

  Mahidol University

  STUDY CHAIR

• Viratch Tangsujaritvijit, Ph.D.

  Piyavate Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 26, 2021
• Study Start: April 19, 2021
• Primary Completion: June 25, 2022
• Study Completion: July 31, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)