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| Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
|---|---|
| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00142493 |
Purpose
The purpose of this research is to understand how some of the drugs commonly used in anesthesia impair memory. We are particularly interested in whether the emotion associated with a memory influences how well these drugs are able to block memory. We are studying four commonly used drugs—propofol, thiopental, midazolam, and dexmedetomidine, all of which may have slightly differing effects. We will also study an inactive substance, called a placebo, that should have no effect. The results of this study will provide information that will be useful in understanding how memory works, how these drugs affect memory, and possibly why some people don't have their memory blocked as easily as others.
| Condition | Intervention | Phase |
|---|---|---|
|
Memory Losses Amnesia-Memory Loss |
Drug: Propofol Drug: Thiopental Sodium Drug: Dexmedetomidine Hydrochloride Drug: Midazolam Hydrochloride Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Effect of Affective Content on Drug Induced Amnesia of Episodic Memory |
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2004 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Propofol
1.2ug/ml
|
| 2: Experimental |
Drug: Thiopental Sodium
2.0ug/ml
|
| 3: Experimental |
Drug: Dexmedetomidine Hydrochloride
0.5ng/ml
|
| 4: Experimental |
Drug: Midazolam Hydrochloride
60ng/ml
|
| 5: Placebo Comparator |
Drug: placebo
intralipid, saline, saline with multi-Vit solution
|
The protocol "Effect of Affective Content on Drug Induced Amnesia of Episodic Memory" investigates the relationship between the ability of affective ('emotional') content to modulate the formation of episodic memory, and the memory impairment ('amnestic') effects of several common intravenous anesthetic drugs. Because memory modulation by affective content appears to be a distinct memory process, the underlying question is whether drugs that impair memory via different mechanisms will have differing effects on memory modulation. Specifically, the objectives are: (1) To study the influence of three GABAergic agents (thiopental, propofol, and midazolam) and one α2-adrenergic agent (dexmedetomidine) on the ability of affective content to modulate the strength of episodic memory; and (2) To study whether the subliminal ('consciously imperceptible') presentation of emotional words can influence memory for visual stimuli shown immediately after the subliminal presentation.
A maximum of eighty volunteers will receive sub-anesthetic doses of one of the four study drugs, or placebo, while performing a visual continuous recognition task ('CRT') of pictures with randomly varying affective load. Drug effect on affective modulation of working and early long-term memory behavior will be examined by analyzing which images are and are not recognized during the CRT. Drug effect on affective modulation of later long-term memory will be examined by analyzing which images are recognized several hours after presentation.
In a second experiment, emotive and non-emotive words are subliminally presented immediately before the presentation of a 'bland' picture. The ability of the subliminally presented word to influence memory will be examined by analyzing which bland images are recognized several hours later.
Three hypotheses are tested:
The memory impairment effected by GABAergic drugs will be stronger for memory of emotively positive images than for memory of emotively negative images
The memory impairment effected by dexmedetomidine will be similar for memory of emotively positive and negative images
Recognition memory for neutral, non-arousing images will be greater if the image is immediately preceded by the subliminal presentation of an emotively arousing word than if it is preceded by an emotively non-arousing word
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Kane O. Pryor, M.D. | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan Kettering Cancer Center ( Kane Pryor, MD ) |
| Study ID Numbers: | 04-087 |
| Study First Received: | August 31, 2005 |
| Last Updated: | September 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00142493 |
| Health Authority: | United States: Institutional Review Board |
|
Episodic Memory Amnesia Amnesia, Temporary |
|
Thiopental Midazolam Memory Disorders Cognition Disorders Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Neurologic Manifestations Dexmedetomidine Dementia Propofol Neurobehavioral Manifestations Amnesia Delirium |
|
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Anesthetics Adrenergic Agonists Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Anesthetics, Intravenous |
Tranquilizing Agents Adrenergic alpha-Agonists Nervous System Diseases Central Nervous System Depressants Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General Analgesics, Non-Narcotic GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |
