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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-05-10

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.

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Detailed Description

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Conditions

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Pediatric Pateints Amnesic Properties of Propofol

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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children going under sedation with 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.

Group Type EXPERIMENTAL

memory test

Intervention Type OTHER

Propofol

Intervention Type DRUG

children not going under sedation

A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.

Group Type ACTIVE_COMPARATOR

memory test

Intervention Type OTHER

Interventions

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memory test

Intervention Type OTHER

Propofol

Intervention Type DRUG

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)

Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No