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

April 4, 2017 updated by: Ahmet Selim Ozkan, Inonu University

The Effects of Nitrogen Protoxide + Sevoflurane and Oxygen + Sevoflurane Anesthesia 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: corneal endothal
Evaluate the effects of nitrogen protoxide to corneal endothal and compare with oxygen.
Other: Nitrogen protoxide
Other: Oxygen
ACTIVE_COMPARATOR: Cell density
Evaluate the effects of nitrogen protoxide to Cell density and compare with oxygen.
Other: Nitrogen protoxide
Other: Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after surgery at first day, 1th week and 1th month
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
after surgery at first day, 1th week and 1th month
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
at before surgery and 1 week and 1 month after surgery
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
after surgery at first day, 1th week and 1th month
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
after surgery at first day, 1th week and 1th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

April 4, 2017

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

December 27, 2016

First Posted (ESTIMATE)

December 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asozkan-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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