Providing "Good Sleep" for ICU Sedation (ASRV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01342328|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2011
Last Update Posted : May 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorders||Other: Normal saline infusion Drug: Dexmedetomidine Drug: Propofol||Not Applicable|
In this proposal the investigators seek 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), two common widely used sedative agents in ICU. Ten volunteers will be enrolled and each subject will be studied on three experimental sessions. Subjects will be randomized to receive a continuous infusion of either saline, dexmedetomidine (DEX), or propofol in each of the three sessions. By relying on clinical rating scales, the investigators ensure that the doses of DEX and propofol administered induce equisedative states before progressing to magnetoencephalography and electroencephalography data collection.
If the restorative and reparative benefits of sleep mitigate the development of cognitive dysfunction, this will result in shorter ICU length of stay for critically ill patients with a concomitant reduction in healthcare costs. Furthermore, it is possible that the restorative properties of sleep for the central nervous system can extend to the immune system with less infection and/or greater likelihood of survival from sepsis.
In this manner, our project will translate experimental data towards clinical practice and the adoption of rational and clinically supported interventions in the ICU that are likely to improve not only patient reported outcome measures, but also the chance of surviving critical illness.
Each experimental session will take a maximum of 7 hours (5 hours maximum for control sessions).
Sessions have to be separated by at least one week. Subjects will be enrolled for a minimum of 3 weeks (1 session on each week) and no more than 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Providing "Good Sleep" for ICU Sedation|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
Placebo Comparator: Control
For this arm, the volunteer subject will receive a saline infusion during the sleep session.
Other: Normal saline infusion
Normal saline infusion
Experimental: Dexmedetomidine (DEX)
For this arm, the volunteer subject will receive a DEX infusion for sedation during the sleep session.
Infusion of Dexmedetomidine will be administrated during the overnight sleep study. An initial target concentration of 0.25 ng/ml will be selected. After 5 min, the sedative point will be assessed and the concentration will be adjusted stepwise by increments and decrements of 0.05 ng/ml. This process will be repeated until the target sedative state is achieved. Using the Richmond Agitation Sedation Scale (RASS) infusion rates, using known pharmacokinetic parameters will be adjusted to achieve equivalent levels of sedation (RASS -3) for both DEX and propofol sessions.
We aim to achieve an RASS of -3 so that the subjects are "moderately sedated". This state of sedation will be maintained for 3-4 hours.
For this arm, the volunteer subject will receive a propofol infusion for sedation during the sleep session.
For propofol, an initial concentration of 0.75 ng/ml will be targeted. Depending on the score achieved, the infusion rate will be increased or decreased every 5 min by 0.2 ng/ml until the target sedative state is achieved.
Note that the target sedative state (RASS score of -3) is the same for both DEX and propofol sessions, with the investigator being unaware of which drug is being administered. To ensure the investigator is not aware of the type of drug being administered, all drug delivery systems will be covered.
Intravenous drug delivery will be continued throughout the scanning period for 3-4 hours to maintain equivalent levels of sedation for both DEX and propofol.
Other Name: Diprivan
- Compare the electroencephalography features of sleep produced by three sleep-induced regimens [ Time Frame: Data will be collected during patient's sleep, which will last 4hours. ]The investigators will evaluate the "power" in the delta rhythm range and amount of slow-wave-sleep
- Compare the magnetoencephalography features of sleep produced by three sleep induced regimens [ Time Frame: Data will be collected during patient's sleep, which will last 4hours. ]The investigators will evaluate the magnetoencephalography-defined brain connectivity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342328
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Mervyn Maze, MB, ChB||University of California, San Francisco|