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

Not Applicable

Completed

• Conditions: Cornea; Anesthesia; Reaction
• Interventions: Other: Nitrogen protoxide; Other: Oxygen

• Registration Number: NCT03006211
• Lead Sponsor: Inonu University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-30
• Primary Completion: 2017-02
• Status Verified: 2017-04
• Study Completion: 2017-04-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 40 eyes of 40 pediatric patients who had extraocular surgery under general anesthesia

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
corneal endothal	Oxygen	Evaluate the effects of nitrogen protoxide to corneal endothal and compare with oxygen.
corneal endothal	Nitrogen protoxide	Evaluate the effects of nitrogen protoxide to corneal endothal and compare with oxygen.
Cell density	Oxygen	Evaluate the effects of nitrogen protoxide to Cell density and compare with oxygen.
Cell density	Nitrogen protoxide	Evaluate the effects of nitrogen protoxide to Cell density and compare with oxygen.

Primary Outcome Measures

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