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

December 14, 2017 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Propofol
Other: memory test
ACTIVE_COMPARATOR: 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.
Other: memory test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Eric Kelhoffer, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2012

Primary Completion (ACTUAL)

May 10, 2017

Study Completion (ACTUAL)

May 10, 2017

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (ESTIMATE)

October 29, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2018

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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