Pharmacokinetic/Pharmacodynamic Model of Propofol in Children

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

By measuring plasmatic concentration of propofol at different intervals during surgery of children aged 1 to 12 years old and measuring Bispectral Index (BIS) as a surrogate for cerebral activity, the investigators aim to create a pharmacokinetic/pharmacodynamic model of propofol for children.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pontificia Universidad Catolica de Chile
• Treatments: Propofol

Criteria

Inclusion Criteria:

• Children aged 1 year through 11 years 11 months and 29 days old.

• American Society of Anesthesiology (ASA) score 1 or 2.

• Elective surgery of more than 1 hour of expected duration.

• Written informed consent signed by parents or legal guardians.

• Oral and written consent in children aged over 7 years old.

Exclusion Criteria:

• Known allergies to study drugs.

• Use of any medication acting on central nervous system in the last 24 hours previous to surgery.

• Chronic cardiac, renal, hepatic or neurologic disease that determines abnormal function.

• Difficult airway (predicted or known).

• Use of neuraxial anesthesia.