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NCT01342328 · ClinicalTrials.gov registry record · Phase 1
Providing "Good Sleep" for ICU Sedation
A Phase 1 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01342328 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 3 participants.
The verdict
NCT01342328, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG Dexmedetomidine
- DRUG Propofol
- OTHER Normal saline infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01342328
The ClinicalTrials.gov registry entry for NCT01342328 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dexmedetomidine is the first listed.
NCT01342328 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01342328 about?
NCT01342328 is a clinical study titled "Providing "Good Sleep" for ICU Sedation". 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 in...
What is the current status of trial NCT01342328?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2012-05. Estimated completion is 2012-11-01.
What interventions are being tested in trial NCT01342328?
The interventions under investigation include: Dexmedetomidine (DRUG), Propofol (DRUG), Normal saline infusion (OTHER).
Who is sponsoring clinical trial NCT01342328?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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