Clinical Trials Logo
  1. Home
  2. Anesthesia
  3. NCT03972852
  4. Details
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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas