NCT03006211

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

December 22, 2016

Last Update Submit

April 4, 2017

Conditions

CorneaAnesthesia; Reaction

Keywords

nitrogen protoxideoxygencorneal endothelialpediatric

Outcome Measures

Primary Outcomes (5)

  • Change of corneal endothal number

    Nitrogen protoxide and oxygen may be change this number

    after surgery at first day, 1th week and 1th month

  • Change of Cell density rate

    Nitrogen protoxide and oxygen may be change this rate

    after surgery at first day, 1th week and 1th month

  • 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

  • Change of Hexagonality rate

    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

    Nitrogen protoxide and oxygen may be change these results

    after surgery at first day, 1th week and 1th month

Study Arms (2)

corneal endothal

ACTIVE COMPARATOR

Evaluate the effects of nitrogen protoxide to corneal endothal and compare with oxygen.

Other: Nitrogen protoxideOther: Oxygen

Cell density

ACTIVE COMPARATOR

Evaluate the effects of nitrogen protoxide to Cell density and compare with oxygen.

Other: Nitrogen protoxideOther: Oxygen

Interventions

Nitrogen protoxideOTHER
Cell densitycorneal endothal
OxygenOTHER
Cell densitycorneal endothal

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal Diseases

Interventions

Nitrous OxideOxygen

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsChalcogensElements

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 30, 2016

Study Start

December 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 4, 2017

Last Updated

April 5, 2017

Record last verified: 2017-04