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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02152787

Enrollment

Registered

2014-06-02

Start date

2014-05-31

Completion date

2016-01-31

Last updated

2014-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strabismus

Keywords

emergence agitation, propofol, strabismus surgery, children, elective strabismus surgery

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.

Interventions

DRUGInjection of propofol 1.0mg/kg

DRUGpropofol 0.5mg/kg

DRUGnormal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

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.

Design outcomes

Primary

Measure	Time frame
The incidence of the emergence agitation	from extubation up to 1 hour

Secondary

Measure	Time frame	Description
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.

Countries

South Korea

Contacts

Primary ContactMin-Soo KIM, MD

kmsviola@yuhs.ac02-2019-3522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026