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

Delirium Clinical Trial

Official title: Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists

Status Terminated

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Delirium
• Respiratory Failure
• Respiratory Insufficiency

• NCT number: NCT00826553
• Study type: Interventional
• Source: Vanderbilt University Medical Center
• Status: Terminated
• Phase: Phase 1
• Start date: January 2009
• Completion date: December 2013