Overview

This trial is active, not recruiting.

Conditions pediatric pateints, amnesic properties of propofol
Treatments memory test, propofol
Sponsor Memorial Sloan Kettering Cancer Center
Start date February 2012
End date February 2017
Trial size 69 participants
Trial identifier NCT02278003, 12-006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(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.
memory test
propofol
(Active Comparator)
A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.
memory test

Primary Outcomes

Measure
sedation threshold
time frame: 1 year

Secondary Outcomes

Measure
Memory threshold
time frame: 1 year

Eligibility Criteria

Male or female participants from 4 years up to 14 years old.

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)

Additional Information

Official title A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients
Principal investigator Eric Kelhoffer, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.