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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

Page last updated: August 20, 2015

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