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OpenTrials
Completed

NCT Number: NCT02278003

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

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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Key information

Conditions

Pediatric Pateints Amnesic Properties of Propofol

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

memory test

Other

Propofol

Drug

Primary outcomes

  1. Sedation Threshold

    Time frame: 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 outcomes

  1. Memory Threshold

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 29, 2014
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.