Comparison of Propofol 1mg/kg and Propofol 0.5mg/kg for Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia

Not Applicable

• Conditions: Strabismus
• Interventions: Drug: normal saline; Drug: Injection of propofol 1.0mg/kg; Drug: propofol 0.5mg/kg

• Registration Number: NCT02152787
• Lead Sponsor: Yonsei University

Brief Summary

The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. Among various strategies for reducing the incidence and severity of EA, the use of pharmacological agents at the end of anesthesia is thought to be the most convenient and easily applicable method in clinical situation. The one of typical agents that can be administered in this way is propofol. Previous studies demonstrated that the use of propofol 1mg/kg at the end of anesthesia could reduce the incidence of EA with low incidence of postoperative nausea and vomiting. However, it was also demonstrated that the use of propofol 1mg/kg at the end of anesthesia could delay the emergence time. The purpose of this study is to compare the preventive effect on EA and the emergence time between propofol 1mg/kg and propofol 0.5mg/kg administered at the end of sevoflurane anesthesia.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-02
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-09
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. children (3-12 years old) scheduled for elective strabismus surgery undergoing general anesthesia.
2. ASA 1-2

Read More

Exclusion Criteria

1. Patients with developmental disability, mental retardation, neurologic disorder, ongoing neurologic medication such as anticonvulsant, previously undergoing general anesthesia, a recent history of upper respiratory infection, parents difficult to read or understand the informed consent.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3) normal saline group	normal saline	According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery
1) propofol 1.0mg/kg group	Injection of propofol 1.0mg/kg	According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery
2) propofol 0.5mg/kg group	propofol 0.5mg/kg	According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery

Primary Outcome Measures

Name	Time	Method
The incidence of the emergence agitation	from extubation up to 1 hour

Secondary Outcome Measures

Name	Time	Method
the emergence time	within the first 1hour after end of strabismus surgery	The emergence time was defined as the time from discontinuation of sevoflurane to extubation.

Trial Locations

Locations (1)

Gangnam Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of