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NCT03132688 Clinical Trial

A Study on Safety and Efficacy of Propofol in Small Children Under 2 Years of Age

Anesthesia; Functional Clinical Trial

Official title:
A Retrospective Study on Safety and Efficacy of Propofol in Small Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03132688
Other study ID # H1612-136-821
Secondary ID
Status Completed
Phase N/A
First received February 21, 2017
Last updated April 26, 2017
Start date April 20, 2017
Est. completion date April 22, 2017

Study information
Verified date April 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This retrospective study the safety and efficacy of intravenous propofol used in children under 2 years of age during general anesthesia for surgery.

Description:

EMR review of intravenous propofol used in target controlled infusion method in children under 2 years old.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 22, 2017
Est. primary completion date April 22, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 2 Years
Eligibility Inclusion Criteria:

- Children under 2 years of age

- Children who received intravenous propofol for maintenance of anesthesia

Exclusion Criteria:

- Children who underwent general anesthesia with inhalational anesthetics

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol
Intravenous administration with dose of 100-200mcg/kg/min

Locations
Country Name City State
Korea, Republic of SNUH Seoul Jongro Gu

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety: blood pressure blood pressure Intraoperative 1 day
Primary Safety: blood pressure blood pressure Intraoperative 7th days
Secondary Bispectral index optimal surgical condition Intraoperative
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