Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty

• Sponsor: Asan Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04683978
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cleft Palate	Other: Position

Study Design

• Study Type: Observational
• Actual Enrollment: 37 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty
• Actual Study Start Date: Feb 10, 2021
• Actual Primary Completion Date: Dec 22, 2021
• Actual Study Completion Date: Dec 23, 2021

Outcome Measures

Primary Outcome Measures

1. Intraocular pressure after neck extension [at 5 minutes after the position change (neck extension)]

   Intraocular pressure after neck extension during palatoplasty

Secondary Outcome Measures

1. Intraocular pressure 10 minutes after anesthetic induction [at 10 minutes after anesthetic induction (supine position)]

   Intraocular pressure 10 minutes after anesthetic induction during palatoplasty

2. Intraocular pressure at end of surgery [immmediately after skin closure (neck extension)]

   Intraocular pressure at end of surgery with neck extension

3. Intraocular pressure 5 minutes after supine position [at 5 minutes after the position change to the supine position (after the end of the surgery)]

   Intraocular pressure 5 minutes after supine position

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 24 Months
• Sexes Eligible for Study: 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan medical Center	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

• Asan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young-Kug Kim, MD, Professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT04683978
• Other Study ID Numbers: 2020-1854
• First Posted: Dec 24, 2020
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cleft Palate

Study Results

No Results Posted as of Feb 16, 2022