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Completed

NCT Number: NCT04683978

Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty

The purpose of this study is to investigate the change in intraocular pressure according to the neck extension during palatoplasty in pediatric patients.

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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, 05505, South Korea

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 with ASA class 1-2
  • Patients who agree to voluntarily participate in this study

Exclusion criteria

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

Treatment and study plan

Position

Other

Neck extension

Primary outcomes

  1. Intraocular pressure after neck extension

    Time frame: at 5 minutes after the position change (neck extension)

    Intraocular pressure after neck extension during palatoplasty

Secondary outcomes

  1. Intraocular pressure 10 minutes after anesthetic induction

    Time frame: at 10 minutes after anesthetic induction (supine position)

    Intraocular pressure 10 minutes after anesthetic induction during palatoplasty

  2. Intraocular pressure at end of surgery

    Time frame: immmediately after skin closure (neck extension)

    Intraocular pressure at end of surgery with neck extension

  3. Intraocular pressure 5 minutes after supine position

    Time frame: at 5 minutes after the position change to the supine position (after the end of the surgery)

    Intraocular pressure 5 minutes after supine position

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2020
Registry last updated
Feb 16, 2022

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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