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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00576615 |
The purpose of this study is to relate changes in the blood flow in your brain which are measured using magnetic resonance imaging (MRI) to temporary changes in your memory and level of sleepiness while receiving the drug propofol, which is commonly used to induce relaxation or sleepiness for minor surgical procedures. This study will help provide us information which will be useful in understanding which parts of the brain are influenced by these drugs to affect memory and sleepiness.
Condition | Intervention |
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Healthy |
Drug: Placebo solution Drug: propofol |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | CNS Targets of Propofol's Hypnotic and Memory Effects |
Estimated Enrollment: | 100 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1: placebo
placebo solution
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Drug: Placebo solution
On the day of the study infusion into the vein of a solution containing no drug, Complete about half a dozen memory tasks over the period of the study, each about 5-10 minutes in length, that involve identification of a list of words, or listen to a list of words/tones before, during, and/or after drug infusion. Allow the recording of your brain waves - the faint electrical activity constantly occurring in your brain- using the electroencephalogram (EEG) while completing memory tasks. Allow the imaging of your brain using functional magnetic resonance imaging (MRI), which measures images of water in your brain in a strong magnetic field, while completing memory tasks.
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2: propofol
propofol
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Drug: propofol
On the study day you will receive study drug propofol. Complete about half a dozen memory tasks over the period of the study, each about 5-10 minutes in length, that involve identification of a list of words, or listen to a list of words/tones before, during, and/or after drug infusion. Allow the recording of your brain waves - the faint electrical activity constantly occurring in your brain- using the electroencephalogram (EEG) while completing memory tasks. Allow the imaging of your brain using functional magnetic resonance imaging (MRI), which measures images of water in your brain in a strong magnetic field, while completing memory tasks. |
We wish to seek evidence of a neuroanatomical basis for the separation of the sedative/hypnotic and amnesic effects of propofol by imaging electrophysiologic and regional cerebral blood flow (rCBF) changes to identify these. Our main hypothesis is that there are differing neuroanatomical regions mediating drug-induced sedation and amnesia, and that these can be identified by specific changes in electrophysiology and rCBF.
Electrophysiologic changes will be mapped using a validated electroencephalographic (EEG) mapping technique, Low Resolution brain Electromagnetic Tomography (LORETA). (1) Changes in brain activity will be identified with high spatial resolution using magnetic resonance imaging (MRI) and statistical parametric mapping (SPM). (2) To identify key regions out of possibly many exhibiting changes in brain activity during propofol administration, we plan to manipulate drug-induced sedation by using thiopental, a sedative drug with few memory effects active at the same receptors as propofol.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
MSKCC clinics
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert Veselis, MD | 212-639-7724 | veselisr@mskcc.org |
Contact: Ruth Reinsel, PhD | 212-639-8111 | reinselr@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Robert Veselis, MD 212-639-7724 veselisr@mskcc.org | |
Contact: Ruth Reinsel, PhD 212-639-8111 reinselr@mskcc.org | |
Principal Investigator: Robert Veselis, MD |
Principal Investigator: | Robert Veselis, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Robert Veselis, MD ) |
Study ID Numbers: | 01-139 |
Study First Received: | December 18, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00576615 History of Changes |
Health Authority: | United States: Institutional Review Board |
healthy volunteers amnesic effects |
Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives Anesthetics |
Central Nervous System Depressants Healthy Propofol |
Anesthetics, Intravenous Anesthetics, General Therapeutic Uses Physiological Effects of Drugs Hypnotics and Sedatives |
Anesthetics Central Nervous System Depressants Propofol Central Nervous System Agents Pharmacologic Actions |