Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty

February 14, 2022 updated by: Young-Kug Kim, MD, Asan Medical Center
The purpose of this study is to investigate the change in intraocular pressure according to the neck extension during palatoplasty in pediatric patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older and under 24 months

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure after neck extension
Time Frame: at 5 minutes after the position change (neck extension)
Intraocular pressure after neck extension during palatoplasty
at 5 minutes after the position change (neck extension)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 10 minutes after anesthetic induction (supine position)
Intraocular pressure at end of surgery
Time Frame: immmediately after skin closure (neck extension)
Intraocular pressure at end of surgery with neck extension
immmediately after skin closure (neck extension)
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
at 5 minutes after the position change to the supine position (after the end of the surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Actual)

December 22, 2021

Study Completion (Actual)

December 23, 2021

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1854

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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