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

Completed

• Conditions: Heart Rate Low; Anesthesia; Functional
• Interventions: Drug: Propofol

• Registration Number: NCT03132688
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-21
• Status Verified: 2017-04
• Study Start: 2017-04-20
• Primary Completion: 2017-04-22
• Study Completion: 2017-04-22
• Study First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Study First Posted: 2017-04-28
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Children under 2 years of age
• Children who received intravenous propofol for maintenance of anesthesia

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Exclusion Criteria

• Children who underwent general anesthesia with inhalational anesthetics

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children < 2 years old	Propofol	Children under 2 years of age who received intravenous propofol during general anesthesia.

Primary Outcome Measures

Name	Time	Method
Safety: blood pressure	Intraoperative 7th days	blood pressure

Secondary Outcome Measures

Name	Time	Method
Bispectral index	Intraoperative	optimal surgical condition

Trial Locations

Locations (1)

SNUH; 🇰🇷 Seoul, Jongro Gu, Korea, Republic of