A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients

Study Overview
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Brief Summary
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The goal of this study is to extend findings of propofol's effects on memory, as measured in volunteer research studies, to a clinical setting.

Official Title
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A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients

Conditions
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Pediatric Pateints, Amnesic Properties of Propofol

Intervention / Treatment
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* Other: memory test
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be between 4 and 14 yrs of age and be undergoing a therapeutic or diagnostic procedure with or without sedation The patient must be able to comprehend and perform the task (naming pictures) The patient must have a minimum weight of 8 kg Exclusion Criteria: Allergy to propofol (for those patients requiring sedation) Procedure of short duration (< 15 min) Pregnancy Recent use (within 5 half-lives) of centrally acting medications that could affect concentration (e.g. diphenhydramine)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: children going under sedation with propofol<br>Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of propofol. measure the amnesic effects of propofol. | Other: memory test<br> <br> Drug: Propofol<br> <br> |
| Active Comparator: children not going under sedation<br>A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory. | Other: memory test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation Threshold | During the 10-minute infusion of propofol, children will be presented with pictures at 5-second intervals and asked to name the picture. They will be asked to name each picture (e.g., cat, tree, pencil, etc.). A valid response is naming of the picture within 5 seconds, either correctly or incorrectly.The important response measure is whether the child is awake enough to perform the naming task. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory Threshold | At the presentation of each picture, the child will be asked whether or not he/she remembers having seen it previously. Each response will be coded as correct (true positives and true negatives) or incorrect (false positives and false negatives). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amnesic, Propofol, 12-006