A Phase 1 interventional study of Propofol and Thiopental Sodium in Memory Losses and Amnesia-Memory Loss, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-24.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment
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.
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
22 studies on the registry are indexed under Amnesia; 2 are open to participants now.
This study's enrollment of 79 is above the median of 62 across 19 interventional studies indexed under Amnesia.
Browse Amnesia studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.
Compared within Amnesia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Memory Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Propofol
Drug: Thiopental Sodium
Drug: Dexmedetomidine Hydrochloride
Drug: Midazolam Hydrochloride
Drug: placebo
1.2ug/ml
2.0ug/ml
0.5ng/ml
60ng/ml
intralipid, saline, saline with multi-Vit solution
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
Time frame: over a two day period
To study whether the subliminal ('consciously imperceptible') presentation of emotional words can influence memory for visual stimuli shown immediately after the subliminal presentation
Time frame: over a two day period
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Propofol · Thiopental · Dexmedetomidine · Midazolam
Memorial Sloan Kettering Cancer Center →