NCT02278003

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 10, 2018

Completed
Last Updated

January 10, 2018

Status Verified

June 1, 2017

Enrollment Period

5.3 years

First QC Date

October 24, 2014

Results QC Date

November 20, 2017

Last Update Submit

December 14, 2017

Conditions

Pediatric PateintsAmnesic Properties of Propofol

Keywords

AmnesicPropofol12-006

Outcome Measures

Primary Outcomes (1)

  • Sedation Threshold

    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 Outcomes (1)

  • Memory Threshold

    1 year

Study Arms (2)

children going under sedation with propofol

EXPERIMENTAL

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 testDrug: Propofol

children not going under sedation

ACTIVE COMPARATOR

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

Other: memory test

Interventions

memory testOTHER
children going under sedation with propofolchildren not going under sedation
PropofolDRUG
children going under sedation with propofol

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • Veselis R, Kelhoffer E, Mehta M, Root JC, Robinson F, Mason KP. Propofol sedation in children: sleep trumps amnesia. Sleep Med. 2016 Nov-Dec;27-28:115-120. doi: 10.1016/j.sleep.2016.10.002. Epub 2016 Oct 22.

    PMID: 27938911DERIVED

Related Links

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Eric Kelhoffer, MD
Organization
Memorial Sloan Kettering Cancer Center
kelhoffe@mskcc.org
212-639-8781

Study Officials

  • Eric Kelhoffer, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2014

First Posted

October 29, 2014

Study Start

February 1, 2012

Primary Completion

May 10, 2017

Study Completion

May 10, 2017

Last Updated

January 10, 2018

Results First Posted

January 10, 2018

Record last verified: 2017-06

Locations

US(1)