Propofol's Hypnotic and Memory Effects - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00576615

Purpose

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
Healthy	Drug: Placebo solution Drug: propofol

MedlinePlus related topics: MRI Scans Memory

Drug Information available for: Propofol

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	CNS Targets of Propofol's Hypnotic and Memory Effects

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Identify the neuroanatomical regions mediating propofol-induced amnesia and sedation. [ Time Frame: fifteen hours over several different days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
1: placebo placebo solution	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.
2: propofol propofol	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.

Groups/Cohorts

Assigned Interventions

1: placebo

placebo solution

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.

2: propofol

propofol

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

MSKCC clinics

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576615

Contacts

Contact: Robert Veselis, MD	212-639-7724	veselisr@mskcc.org
Contact: Ruth Reinsel, PhD	212-639-8111	reinselr@mskcc.org

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Robert Veselis, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

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
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

healthy volunteers
amnesic effects

Study placed in the following topic categories:

Healthy
Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009