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NCT03006211 Clinical Trial

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

Cornea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03006211
Other study ID # Asozkan-4
Secondary ID
Status Completed
Phase N/A
First received December 22, 2016
Last updated April 4, 2017
Start date December 2016
Est. completion date April 4, 2017

Study information
Verified date April 2017
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 4, 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Nitrogen protoxide

• Oxygen

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Inonu University

Outcome
Type Measure Description Time frame Safety issue
Primary Change of corneal endothal number Nitrogen protoxide and oxygen may be change this number after surgery at first day, 1th week and 1th month
Primary Change of Cell density rate Nitrogen protoxide and oxygen may be change this rate after surgery at first day, 1th week and 1th month
Primary 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
Primary Change of Hexagonality rate Nitrogen protoxide and oxygen may be change this rate after surgery at first day, 1th week and 1th month
Primary 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
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