Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty

Cleft Palate Clinical Trial

Official title:

Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04683978
• Other study ID #: 2020-1854
• Status: Completed
• Start date: February 10, 2021
• Est. completion date: December 23, 2021

Study information

• Verified date: February 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 23, 2021
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Other:
• Position
Neck extension

Locations

Country	Name	City	State
Korea, Republic of	Asan medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure after neck extension	Intraocular pressure after neck extension during palatoplasty	at 5 minutes after the position change (neck extension)
Secondary	Intraocular pressure 10 minutes after anesthetic induction	Intraocular pressure 10 minutes after anesthetic induction during palatoplasty	at 10 minutes after anesthetic induction (supine position)
Secondary	Intraocular pressure at end of surgery	Intraocular pressure at end of surgery with neck extension	immmediately after skin closure (neck extension)
Secondary	Intraocular pressure 5 minutes after supine position	Intraocular pressure 5 minutes after supine position	at 5 minutes after the position change to the supine position (after the end of the surgery)