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Clinical Trials/NCT03585608
NCT03585608
Completed
Not Applicable

Effect of Neck Extension on Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty

Asan Medical Center2 sites in 1 country30 target enrollmentStarted: July 18, 2018Last updated:
ConditionsCleft Palate

Overview

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Difference in optic nerve sheath diameter

Overview

Brief Summary

The purpose of this study is to evaluate the change of the optic nerve sheath diameter according to the change of the neck position in pediatric patients undergoing palatoplasty.

Detailed Description

Palatoplaty is performed under neck extension in patients with cleft palate. The purpose of this study is to evaluate the effect of neck extension on the ultrasonographic optic nerve sheath diameter during palatoplasty.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
6 Months to 24 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older and under 24 months
  • Patients who agree to voluntarily participate in this study
  • Patients with ASA class 1-2

Exclusion Criteria

  • History of diagnosis of neurologic or ophthalmic disease
  • History of neurosurgery or ophthalmic surgery
  • Patients who refused to participate in clinical studies

Outcomes

Primary Outcomes

Difference in optic nerve sheath diameter

Time Frame: 10 minutes after neck extension

Difference between the optic nerve sheath diameter measured during supine position without neck extension and the optic nerve sheath diameter measured during supine position with neck extension in patients undergoing palatoplasty

Secondary Outcomes

  • Difference in optic nerve sheath diameter(at end of surgery with the neck extended)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Young-Kug Kim

Professor

Asan Medical Center

Study Sites (2)

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