A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Pateints; Amnesic Properties of Propofol
Intervention: memory test (Other); Propofol (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): Eric Kelhoffer, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
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.
Clinical Details
Official title: A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: sedation threshold
Secondary outcome: Memory threshold
Eligibility
Minimum age: 4 Years.
Maximum age: 14 Years.
Gender(s): Both.
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)
Locations and Contacts
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Additional Information
Memorial Sloan Kettering Cancer Center
Starting date: February 2012
Last updated: April 28, 2015
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