- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00576615
Propofol's Hypnotic and Memory Effects
CNS Targets of Propofol's Hypnotic and Memory Effects
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy normal volunteers who show no evidence of neurologic deficit on questionnaire and physical examination
- Females of child-bearing age must be non-pregnant as demonstrated using a pregnancy test, non-lactating, and must be using adequate contraception or be surgically sterile
- Age 18 years to 45 years
- Right hand dominant
- High school education or above(to ensure consistent performance on the memory tests being administered)
- English as native language or equivalent degree of fluency
Exclusion Criteria:
- Any evidence of neurologic deficit including seizures, history of severe head trauma or any previously or current abnormal study of CNS - (eg. MRI, EEG, etc.)
- Any deficit in auditory or visual ability that would prevent performance of the study tasks
- History of claustrophobia
- Any history of hypertension (resting BP >150 systolic, >100 diastolic) or taking anti- hypertensive medication
- Any history of cardiovascular disease including previous myocardial infarction, arrhythmia, heart valve disease, or cardiac murmur
- Significant pulmonary, renal, gastrointestinal, or endocrine metabolic disease which in the opinion of the investigator would complicate the goals of this study
- Allergy to propofol, thiopental, eggs or history of acute intermittent porphyria, history of severe allergic reaction (e.g. anaphylactic shock)
- History of substance abuse
- Currently taking centrally acting medications (benzodiazepines or other anxiolytics, antidepressants, antipsychotic agents, or agents affecting the cerebral vasculature)
- Any one who is not NPO for at least 6 hours
- Any implant incompatible with MR scanning
- Anyone who, in the opinion of the investigators, would be unwilling or unable to tolerate the procedures and/or comply with the task instructions
- Body Mass Index (BMI) > 30
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1: placebo
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.
|
2: propofol
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Demonstrate the persistence of defined stimulation-related changes in brain activity during various levels of propofol and thiopental sedation.
Time Frame: fifteen hours over several different days
|
fifteen hours over several different days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identify the neuroanatomical regions mediating propofol-induced amnesia and sedation.
Time Frame: fifteen hours over several different days
|
fifteen hours over several different days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Veselis, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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