CClinicalTrials.gg
Status unknownNCT02152787Updated Jul 9, 2014

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

An interventional study of Injection of propofol 1.0mg/kg and propofol 0.5mg/kg in Strabismus, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2014-07-09.

Sponsored by Yonsei University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
3 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Strabismus

Keywords

  • emergence agitation
  • propofol
  • strabismus surgery
  • children
  • elective strabismus surgery
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's planned enrollment of 90 is close to the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    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

    Drug: Injection of propofol 1.0mg/kg

  • Experimental
    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

    Drug: propofol 0.5mg/kg

  • Placebo comparator
    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

    Drug: normal saline

Interventions

  • DrugInjection of propofol 1.0mg/kg
  • Drugpropofol 0.5mg/kg
  • Drugnormal saline
06

What researchers measure

Primary outcomes

  1. The incidence of the emergence agitation

    Time frame: from extubation up to 1 hour

Secondary outcomes

  1. the emergence time

    The emergence time was defined as the time from discontinuation of sevoflurane to extubation.

    Time frame: within the first 1hour after end of strabismus surgery

07

Study locations

1 of 1 sites recruiting
  • Gangnam Severance Hospital, Yonsei University College of Medicine
    Seoul, 135-720, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02152787
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jun 2, 2014
Start date
May 2014
Primary completion
Dec 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Jul 9, 2014

Study contacts

Min-Soo KIM, MD
Contact
kmsviola@yuhs.ac
02-2019-3522

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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