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

Yonsei University

Status: Unknown

Conditions: Strabismus

Treatments: Drug: normal saline; Drug: propofol 0.5mg/kg; Drug: Injection of propofol 1.0mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT02152787

3-2014-0028

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

1) propofol 1.0mg/kg group

Experimental group

Description:

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

Treatment:

Drug: Injection of propofol 1.0mg/kg

2) propofol 0.5mg/kg group

Experimental group

Description:

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

Treatment:

Drug: propofol 0.5mg/kg

3) normal saline group

Placebo Comparator group

Description:

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

Treatment:

Drug: normal saline