How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units (HYPNOS)

Vanderbilt University Medical Center

Status and phase

Terminated

Phase 1

Conditions

Respiratory Failure

Delirium

Treatments

Drug: GABA agonist

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT00826553

081170

Details and patient eligibility

About

The purpose of this study is to study the effect of two standard of care sedative medications on sleep stages and total sleep time. The investigators hypothesize that the α2 agonist, dexmedetomidine, will improve sleep quality by increasing N2 and N3 sleep as well as total sleep time when compared to GABA agonists.

Full description

This is a single center randomized pilot study comparing the effects of an α2 agonist (dexmedetomidine) versus GABA agonists (propofol or a benzodiazepine) on total sleep time and sleep quality. For the purposes of enrollment and analysis all benzodiazepines used for sedation (mainly midazolam and lorazepam) will be considered equivalent. Patients who are mechanically ventilated and sedated will be enrolled. The initial sedative will be determined by the managing medical team and the medication will be active at the time of enrollment. The patients will then be randomized to either continue their current sedative or be switched to either propofol or dexmedetomidine. PSG data will be collected for up to 96 hours, beginning at enrollment for all patients. The analysis of PSG will not begin until after a 8 hour "washout" period has completed to minimize carryover effect of prior sedatives.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients admitted to the medical intensive care unit who require mechanical ventilation and are sedated with a GABA agonist with the expectation of being mechanically ventilated for greater than 24 hours.

Exclusion criteria

Subjects who are less than 18 years
Subjects who are pregnant (a pregnancy test will be performed on all women of child bearing age)
Inability to obtain informed consent from the patient or his/her surrogate
Subjects who are physiologically benzodiazepine dependent, and at risk of withdrawal syndromes
Subjects with anoxic brain injuries, strokes, or neurotrauma
Medical team following patient unwilling to change sedation regimen
Subjects who are moribund and not expected to survive 24 hours or actively withdrawing medical support
Documented allergy to study medications
Subjects with advanced heart block at time of screening
Prisoners
RASS target of less than or equal to -4 at the time of screening
PSG equipment unavailable