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
• 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
• 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:

Related Conditions & MeSH terms

• Anesthesia; Reaction
• Cornea

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