Anesthesia Clinical Trial
Official title:
Genetic Differences in Pharmacodynamic Safety Endpoints With Propofol Anaesthesia in Children
Verified date | April 2024 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 360 |
Est. completion date | December 2024 |
Est. primary completion date | October 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | BC Children's Hospital - Department of Anesthesia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | BC Children's Hospital Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose of propofol required to produce loss of consciousness | Loss of consciousness will be defined clinically when there is a loss of eyelash reflex, a tolerance of nasal cannulae, and when the Bispectral Index <60 for 30 sec. | Loss of consciousness will be expected to occur somewhere between 120-180 seconds after commencing the induction infusion. | |
Primary | Dose of propofol required to produce apnea | Apnea will be defined as absence of end-tidal CO2 for at least 20 seconds. | Apnea will be expected to occur within 10 min after commencing the induction infusion. | |
Secondary | Self-identified countries of family origin up to grandparents | The participant will report the countries which make up the participant's ancestral background, up to the country of origin of the grandparents. | Within 10 minutes after consent to participate. | |
Secondary | A genotyped/imputed dataset of 8 million genetic variants aggregated using SHAPEIT (v2), IMPUTE2 (v2.3.2), Phase 3 1000 Genomes Project reference panel, SNP2HLA (v1.0.2), and the Type 1 Diabetes Genetics Consortium reference panel. | Extensive genome-wide genotyping to determine genetic variants of the pathways involved in propofol biotransformation. The array captures both common and rare variation collected from large-scale sequencing projects. | Saliva sample collected immediately after apnea, within 10min of propofol infusion start. Genomic analysis will be performed post-hoc. |
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