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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Pediatric Pateints; Amnesic Properties of Propofol

Treatments: Other: memory test; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02278003

12-006

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

children going under sedation with propofol

Experimental group

Description:

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.

Treatment:

Other: memory test

Drug: Propofol

children not going under sedation

Active Comparator group

Description:

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

Treatment:

Other: memory test