A Study on Safety and Efficacy of Propofol in Small Children Under 2 Years of Age
A Retrospective Study on Safety and Efficacy of Propofol in Small Children
1 other identifier
observational
100
1 country
1
Brief Summary
This retrospective study the safety and efficacy of intravenous propofol used in children under 2 years of age during general anesthesia for surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2017
CompletedStudy Start
First participant enrolled
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedApril 28, 2017
April 1, 2017
2 days
February 21, 2017
April 26, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Safety: blood pressure
blood pressure
Intraoperative 1 day
Safety: blood pressure
blood pressure
Intraoperative 7th days
Secondary Outcomes (1)
Bispectral index
Intraoperative
Study Arms (1)
children < 2 years old
Children under 2 years of age who received intravenous propofol during general anesthesia.
Interventions
Eligibility Criteria
Children who underwent surgery From September 2013 to December 2016 , and received intravenous propofol for general anesthesia will be enrolled.
You may qualify if:
- Children under 2 years of age
- Children who received intravenous propofol for maintenance of anesthesia
You may not qualify if:
- Children who underwent general anesthesia with inhalational anesthetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNUH
Seoul, Jongro Gu, 15710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-Soo Kim, PhD
Seoul National University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 21, 2017
First Posted
April 28, 2017
Study Start
April 20, 2017
Primary Completion
April 22, 2017
Study Completion
April 22, 2017
Last Updated
April 28, 2017
Record last verified: 2017-04