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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03006211
Enrollment
40
Registered
2016-12-30
Start date
2016-12-31
Completion date
2017-04-04
Last updated
2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Reaction, Cornea

Keywords

nitrogen protoxide, oxygen, corneal endothelial, pediatric

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.

Interventions

OTHERNitrogen protoxide
OTHEROxygen

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Change of corneal endothal numberafter surgery at first day, 1th week and 1th monthNitrogen protoxide and oxygen may be change this number
Change of Cell density rateafter surgery at first day, 1th week and 1th monthNitrogen protoxide and oxygen may be change this rate
Change of Cell variation rateat before surgery and 1 week and 1 month after surgeryNitrogen protoxide and oxygen may be change this rate
Change of Hexagonality rateafter surgery at first day, 1th week and 1th monthNitrogen protoxide and oxygen may be change this rate
Change of pachymetry specular microscopy resultsafter surgery at first day, 1th week and 1th monthNitrogen protoxide and oxygen may be change these results

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026