Providing "Good Sleep" for ICU Sedation
Stopped early · Phase 1
Conditions studied: Sleep Disorders
In brief
Cognitive dysfunction, either alone or as an element in the syndrome of delirium, is a common occurrence with an incidence as high as 75% in intensive care unit (ICU) patients and can independently result in serious consequences including higher mortality rate. Delirium develops through a complex interaction between the patient's baseline vulnerability (risk factors) and precipitating factors such as disruption of sleep that may occur during hospitalization. While sedative-hypnotic agents that are used to facilitate hypnosis and the management of mechanically ventilated patients converge on the neural substrate that mediate endogenous sleep, they do so at different juncture points depending on its molecular mechanism of hypnotic action. Hypnotic agents that modulate the GABAA receptor converge at the level of the hypothalamus while α2 adrenergic agonists converge on sleep pathways within the brainstem. This translational project seeks to determine whether sedation mediated by activation of α2 adrenoceptors (dexmedetomidine) is more like natural sleep than that provided by a sedative agent that modulates the GABAA receptor (propofol). The investigators will examine volunteers who will be monitored continuously by electroencephalography (EEG) and whole-brain functional connectivity by magnetoencephalography (MEG) during each of three sleep stages, namely, that induced by dexmedetomidine, propofol, or saline (natural sleep, control). The two drug-induced sleep regimens will be compared to natural sleep using EEG and brain connectivity by MEG
Key facts
- Study ID
- NCT01342328
- Run by
- University of California, San Francisco
- People needed
- 3
- Starts
- 2012-05-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Volunteer agreement and written informed consent
- Healthy female or male between 18 and 45 years of age
- Body Mass Index < 30 kg/m2
- Non-pregnant and non-lactating
- Normal airway anatomy (Mallampati class I)
You may not qualify if…
- Subject has a history of recent alcohol or drug abuse
- Subject is unable to communicate in English
- Subject is unwilling to meet fast guidelines (fast light meal or non-human milk for at least 8 hours, and clear liquids at least for 2 hours prior to induction of sedation on the day of the study)
- Subject has taken caffeine containing beverages less than 8 hours before study begins
- Subject is not able to avoid sleep for a minimum of 16 hours prior to testing
- Subject has a known allergy to either of the sedative-hypnotic drugs to be used in the study
- Subject has abnormal airway anatomy, including loose teeth
- Subject has any family history of complications from anesthesia
- Subject has history of sleep apnea
- Subject has any reported illness, upper respiratory tract infection, abnormal vital signs, or concerning findings on the physical exam for the past 6 weeks
- Subject has a positive urine pregnancy test
- Subject is unable to sleep supine.
Where it is running
- University of California San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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