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NCT03972852 Clinical Trial

Establishment of an Anaesthetic Protocol for Examinations for Children With Glaucoma or Suspected Glaucoma

Anesthesia Clinical Trial

— eyeBIS  

Official title:
Establishment of an Anaesthetic Protocol for Examinations Under Anaesthesia for Children With Glaucoma or Suspected Glaucoma - Correlation of Bispectral Index (BIS) and Intraocular Pressure (IOP)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03972852
Other study ID # eyeBIS 1.0
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date April 2022

Study information
Verified date August 2021
Source Johannes Gutenberg University Mainz
Contact Nina Pirlich, MD
Phone 00496131177175
Email pirlich@uni-mainz.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Correct measurement of the intraocular pressure of children with glaucoma or suspected glaucoma is essential for diagnosis and therapy. Despite new non-invasive measurement methods most of the children are uncooperative during the ophthalmological examination. Therefore examination under anaesthesia is needed. A lot of perioperative factors influence the measurement of intraocular pressure. Established and safe anaesthetic regimes have been modified regarding these factors. Aim of the study is to evaluate, if a standardized anaesthetic protocol generates reliable and reproducible measured values.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date April 2022
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Months to 10 Years
Eligibility Inclusion Criteria: - Indication for a general anesthesia (laryngeal mask) and ophthalmological examination and probably surgery - Children with glaucoma or suspected glaucoma - ASA classification I-III - written informed consent of the legal representatives Exclusion Criteria: - Contraindication for a laryngeal mask airway - Known allergy to propofol or remifentanil

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Johannes Gutenberg - Universität Mainz Rhineland Palatinate

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of depth of anesthesia an intraocular pressure The primary outcome measure is the association between intraocular pressure and bispectral index. 1 day
Secondary Bland Altmann Correlation of Applanation tonometry and rebound tonometry Comparison of two different examination tools 1 day
Secondary Normal range of pediatric intraocular pressure Defining the normal range of pediatric intraocular pressure 1 day
Secondary Correlation of the corneal thickness and the intraocular pressure Regression 1 day
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