Gabapentin for Sleep in Critically Ill Patients

• Status: Recruiting
• Trial end date: 2022-01-30
• Target enrollment: 0
• Participant gender: All

Summary

Sleep disruption in the intensive care unit (ICU) is a common comorbidity associated with patient morbidity and distress. There are no recommended pharmacologic interventions for sleep promotion, and many pharmacologic solutions may actually increase the risk of adverse outcomes rather than impart benefits. Gabapentin, an anticonvulsant with applications in neuropathic pain, has been investigated for sleep promotion in various populations of outpatients. Here investigators propose a pilot study of gabapentin as a therapy for sleep disruption in the ICU. Outcomes measured will be sleep quality as measured by RCSQ (Richards-Campbell Sleep Questionnaire), wrist actigraphy, EEG, and BIS monitoring. The goal is to enroll 80 critically ill patients, 40 intubated and 40 non-intubated patients. The study will take place over 2 nights, with baseline sleep measurements occurring on the first night and gabapentin administration with repeat sleep measurements on the second night.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Gabapentin

Criteria

Inclusion Criteria:

1. Admitted to the ICU or step-down unit (neurologic intermediate care center or Pratt 8) for ≥ 24 hours

2. ≥ 1 risk factor for delirium: benzodiazepine use, blood transfusions, age >60 years, dementia, prior coma, pre-ICU emergency surgery or trauma, American Society of Anesthesia (ASA) score > 3, Acute Physiology and Chronic Health Evaluation II (APACHE II) >12, admission because of a neurologic disease, trauma, and the use of psychoactive medication (e.g., antipsychotics, anticonvulsants)

3. Age ≥ 18 years old

4. Anticipated ICU or step-down unit length of stay ≥ 48 hours past time of enrollment

5. Riker score goal of 3 or 4

Exclusion Criteria:

1. Pregnant women

2. Age < 18 years old

3. Wards of the state or prisoners

4. Patients who were considered by their primary physician to be too unstable to undergo this investigation

5. Comatose patients or patients with severe debilitating neurologic disease such as cerebrovascular accidents, intracranial hemorrhage, subdural hematoma, intracranial primary or secondary cancers, or anoxic-hypoxic encephalopathy

6. Moribund patient expected to die within 24 hours

7. Expected change in intubation status within 24 hours of enrollment

8. Gabapentin or pregabalin use in the last 7 days or at baseline

9. Patients with a known sensitivity to gabapentin

10. Currently receiving a non-benzodiazepine hypnotic (i.e. zolpidem, eszopiclone)

11. Need for every hour neurologic checks

12. Creatinine clearance < 15ml/min or need for renal replacement therapy