The Effects of Nitrogen Protoxide and Oxygen on Corneal Endothelial in Pediatric Patients

Study Overview
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Brief Summary
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To evaluate the mean changes in Endothelial Cell and Corneal pachymetry in eyes that operated under N2O + sevoflurane and O2 + sevoflurane general anesthesia.

Detailed Description
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40 eyes of 40 patients who had extraocular surgery under general anesthesia will be included in this prospective study. Cell density, Cell variatio, Hexagonality rate and pachymetry specular microscopy results at before surgery and 1 week and 1 month after surgery will be analyzed. O2 (1 l/min) with 50% air and N2O (1 l/min) with 50% air will be applied to each group with flow rate 2 l/min totally, respectively. The duration of surgery will be recorded.

Official Title
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The Effects of Nitrogen Protoxide + Sevoflurane and Oxygen + Sevoflurane Anesthesia on Corneal Endothelial in Pediatric Patients

Conditions
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Cornea, Anesthesia; Reaction

Intervention / Treatment
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* Other: Nitrogen protoxide
* Other: Oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 eyes of 40 pediatric patients who had extraocular surgery under general anesthesia Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: corneal endothal<br>Evaluate the effects of nitrogen protoxide to corneal endothal and compare with oxygen. | Other: Nitrogen protoxide<br> <br> Other: Oxygen<br> <br> |
| Active Comparator: Cell density<br>Evaluate the effects of nitrogen protoxide to Cell density and compare with oxygen. | Other: Nitrogen protoxide<br> <br> Other: Oxygen<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of corneal endothal number | Nitrogen protoxide and oxygen may be change this number | after surgery at first day, 1th week and 1th month | 
| Change of Cell density rate | Nitrogen protoxide and oxygen may be change this rate | after surgery at first day, 1th week and 1th month | 
| Change of Cell variation rate | Nitrogen protoxide and oxygen may be change this rate | at before surgery and 1 week and 1 month after surgery | 
| Change of Hexagonality rate | Nitrogen protoxide and oxygen may be change this rate | after surgery at first day, 1th week and 1th month | 
| Change of pachymetry specular microscopy results | Nitrogen protoxide and oxygen may be change these results | after surgery at first day, 1th week and 1th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygen, nitrogen protoxide, corneal endothelial, pediatric