Propofol's Hypnotic and Memory Effects

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00576615
First received: December 18, 2007
Last updated: October 29, 2013
Last verified: October 2013

December 18, 2007
October 29, 2013
May 2002
May 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00576615 on ClinicalTrials.gov Archive Site
Identify the neuroanatomical regions mediating propofol-induced amnesia and sedation. [ Time Frame: fifteen hours over several different days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Propofol's Hypnotic and Memory Effects
CNS Targets of Propofol's Hypnotic and Memory Effects

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

MSKCC clinics

Healthy
  • 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.
  • 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.

  • 1: placebo
    placebo solution
    Intervention: Drug: Placebo solution
  • 2: propofol
    propofol
    Intervention: Drug: propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00576615
01-139
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • National Institute of General Medical Sciences (NIGMS)
  • Weill Medical College of Cornell University
Principal Investigator: Robert Veselis, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP