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Completed

NCT Number: NCT03006211

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

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

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Key information

Conditions

Cornea Anesthesia; Reaction Corneal Diseases Eye Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Nitrogen protoxide

Other

Oxygen

Other

Primary outcomes

  1. Change of corneal endothal number

    Time frame: after surgery at first day, 1th week and 1th month

    Nitrogen protoxide and oxygen may be change this number

  2. Change of Cell density rate

    Time frame: after surgery at first day, 1th week and 1th month

    Nitrogen protoxide and oxygen may be change this rate

  3. Change of Cell variation rate

    Time frame: at before surgery and 1 week and 1 month after surgery

    Nitrogen protoxide and oxygen may be change this rate

  4. Change of Hexagonality rate

    Time frame: after surgery at first day, 1th week and 1th month

    Nitrogen protoxide and oxygen may be change this rate

  5. Change of pachymetry specular microscopy results

    Time frame: after surgery at first day, 1th week and 1th month

    Nitrogen protoxide and oxygen may be change these results

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 30, 2016
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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