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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278003
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pediatric Pateints Amnesic Properties of Propofol Other: memory test Drug: Propofol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients
Actual Study Start Date : February 2012
Actual Primary Completion Date : May 10, 2017
Actual Study Completion Date : May 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
Drug Information available for: Propofol

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.

Other: memory test
Drug: Propofol
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



Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278003


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Eric Kelhoffer, MD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02278003    
Other Study ID Numbers: 12-006
First Posted: October 29, 2014    Key Record Dates
Results First Posted: January 10, 2018
Last Update Posted: January 10, 2018
Last Verified: June 2017
Keywords provided by Memorial Sloan Kettering Cancer Center:
Amnesic
Propofol
12-006
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics