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Completed

NCT Number: NCT03585608

Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty

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.

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Key information

Conditions

Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan medical Center, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neck extension

Procedure

The neck extension is routine posture during palatoplasty. We will evaluate the change in optic nerve sheath diameters before and after neck extension.

Primary outcomes

  1. 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

  1. Difference in optic nerve sheath diameter

    Time frame: at end of surgery with the neck extended

    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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2018
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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