Genetic Differences in Propofol Pharmacodynamics in Children

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Propofol is an extensively utilized intravenous sedative and general anesthetic. However, propofol has a narrow therapeutic index, and this means that there is only a small difference in the dose required to produce loss of consciousness and the dose required to produce potentially life-threatening effects such as loss of protective airway reflexes and cessation of spontaneous breathing. Moreover, there is substantial variation between individuals in the doses required to achieve these pharmacodynamic endpoints.

Given the inexorable rise in demand for pediatric sedation and the increasing use of propofol in sedation protocols by non-anaesthesiologists, the purpose of this study is to refine the propofol dosing recommendations to account for pharmacogenomic variability to make procedural sedation safer for children. Experienced users already adjust for age and body weight. This study may enable further refinements according to sex and - novelly - ancestry.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: BC Children's Hospital Research Institute
• Treatments: Propofol

Criteria

Inclusion Criteria:

• Age ≥ 3 to ≤ 18

• ASA physical status classification I-III

• Intravenous induction resulting in apnea clinically appropriate and indicated

Exclusion Criteria:

• Age < 3 or >18

• ASA physical status IV-V

• Propofol induction to apnea not indicated or feasible

• Sedative premedication

• Severe neurological impairment, expected to reduce propofol requirement as judged by the clinical experience of the anaesthetist

• Weight <3%ile or >97%ile for age