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

Sponsor
Inonu University (Other)
Overall Status
Completed
CT.gov ID
NCT03006211
Collaborator
(none)
40
2
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nitrogen protoxide
  • Other: Oxygen
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
Official Title:
The Effects of Nitrogen Protoxide + Sevoflurane and Oxygen + Sevoflurane Anesthesia on Corneal Endothelial in Pediatric Patients
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Apr 4, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change of corneal endothal number [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 [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 [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 [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 [after surgery at first day, 1th week and 1th month]

    Nitrogen protoxide and oxygen may be change these results

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 40 eyes of 40 pediatric patients who had extraocular surgery under general anesthesia
Exclusion Criteria:
  • None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Inonu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmet Selim Ozkan, M.D., Inonu University
ClinicalTrials.gov Identifier:
NCT03006211
Other Study ID Numbers:
  • Asozkan-4
First Posted:
Dec 30, 2016
Last Update Posted:
Apr 5, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Ahmet Selim Ozkan, M.D., Inonu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2017