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

Critically Ill Clinical Trial

— GASWAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818450
• Other study ID #: MURA2021/170
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2022
• Est. primary completion date: June 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Sleep Deprivation

Intervention

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

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital, Mahidol University	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

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. — View Citation

Carrera-Hernández L, Aizpitarte-Pejenaute E, Zugazagoitia-Ciarrusta N, Goñi-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. Engli — View Citation

Devlin JW, Skrobik Y, Gélinas 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. — View 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. — View 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. — View 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. — View 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 advanc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IGF-1	IGF-1 level	At day 0, 1, 3, and 5 after randomization
Primary	Slow-wave sleep	Slow-wave sleep period or deep sleep period	at least 3 consecutive days after randomization
Secondary	All-cause hospital mortality	Rates of all-cause mortality during hospital stay	During hospital stay or death or a maximum of 90 days
Secondary	ICU free days	Days alive and not stay in ICU	During ICU stay or death or a maximum of 28 days
Secondary	Mechanical ventilator free days	Day alive and free of mechanical ventilator	During ICU stay or death or a maximum of 28 days
Secondary	Hospital free days	Days alive and not stay in hospital	During hospital stay or death or a maximum of 90 days
Secondary	Incidence of self-extubation	Number of patients who had self-extubation during ICU stay	During ICU stay or death or a maximum of 28 days
Secondary	Incidence of sleep deprivation	Times per patient-days of sleep deprivation during ICU stay	During ICU stay or death or a maximum of 28 days
Secondary	Delirium free day	Days alive and not having delirium	During ICU stay or death or a maximum of 28 days