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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Strabismus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1) propofol 1.0mg/kg group

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

Group Type EXPERIMENTAL

Injection of propofol 1.0mg/kg

Intervention Type DRUG

2) propofol 0.5mg/kg group

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

Group Type EXPERIMENTAL

propofol 0.5mg/kg

Intervention Type DRUG

3) normal saline group

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Interventions

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Injection of propofol 1.0mg/kg

Intervention Type DRUG

propofol 0.5mg/kg

Intervention Type DRUG

normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No