HealthyNCT00576615
Propofol's Hypnotic and Memory Effects
An observational study of Healthy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: MSKCC clinics
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo solutionDrug
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.
propofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1: placebo | placebo solution Receives: Drug: Placebo solution | |
| 2: propofol | propofol Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the persistence of defined stimulation-related changes in brain activity during various levels of propofol and thiopental sedation.
Measured: fifteen hours over several different days
Secondary outcomes (1)
Identify the neuroanatomical regions mediating propofol-induced amnesia and sedation.
Measured: fifteen hours over several different days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startMay 2002
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Robert Veselis, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576615
- Sponsor's protocol ID
- 01-139
- Status last verified
- May 2016
- First submitted
- 18 Dec 2007
- Last updated
- 6 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CNS Targets of Propofol's Hypnotic and Memory Effects
- ClinicalTrials.gov ID
- NCT00576615
- Acronym / sponsor ID
- 01-139
- Conditions
- Healthy
- Keywords
- healthy volunteers, amnesic effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Weill Medical College of Cornell University
- Study start
- May 2002
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: placebo | – | Drug: Placebo solutionplacebo solution |
| 2: propofol | – | Drug: propofolpropofol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- MSKCC clinics
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo solutionOn 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 | 1: placebo |
| propofolOn 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. | Drug | 2: propofol |
Primary outcome
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
1 secondary outcome
Identify the neuroanatomical regions mediating propofol-induced amnesia and sedation.
Time frame: fifteen hours over several different days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Veselis, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016; AzTrials last refreshed its copy on 2 Nov 2026.