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

Not Applicable

Completed

• Conditions: Pediatric Pateints; Amnesic Properties of Propofol
• Interventions: Other: memory test; Drug: Propofol

• Registration Number: NCT02278003
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2014-10-24
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-29
• Primary Completion: 2017-05-10
• Study Completion: 2017-05-10
• Status Verified: 2017-06
• Results First Submitted: 2017-11-20
• Results First Submitted QC: 2017-12-14
• Last Update Submitted: 2017-12-14
• Results First Posted: 2018-01-10
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
children going under sedation with propofol	memory test	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.
children not going under sedation	memory test	A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.
children going under sedation with propofol	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Sedation Threshold	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Memory Threshold	1 year	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).

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States