CorneaNCT03006211
The Effects of Nitrogen Protoxide and Oxygen on Corneal Endothelial in Pediatric Patients
A study testing Nitrogen protoxide and Oxygen in people with Cornea and Anesthesia; Reaction, run by Inonu University.
Trial summary
To evaluate the mean changes in Endothelial Cell and Corneal pachymetry in eyes that operated under N2O + sevoflurane and O2 + sevoflurane general anesthesia. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cornea, Anesthesia; Reaction
- What is being tested?
- Nitrogen protoxide and Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 4 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 40 eyes of 40 pediatric patients who had extraocular surgery under general anesthesia
Who cannot join
- None
About this study
Official title: 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.
Read the 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.
- Conditions
- Cornea, Anesthesia; Reaction
- Being tested
- Nitrogen protoxide, Oxygen
- Keywords
- nitrogen protoxide, oxygen, corneal endothelial, pediatric
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrogen protoxideOther
OxygenOther
| Study group | Role | What they receive |
|---|---|---|
| corneal endothal | Active comparator | Evaluate the effects of nitrogen protoxide to corneal endothal and compare with oxygen. Receives: Other: Nitrogen protoxide; Other: Oxygen |
| Cell density | Active comparator | Evaluate the effects of nitrogen protoxide to Cell density and compare with oxygen. Receives: Other: Nitrogen protoxide; Other: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of corneal endothal number
Nitrogen protoxide and oxygen may be change this number
Measured: after surgery at first day, 1th week and 1th month
Change of Cell density rate
Nitrogen protoxide and oxygen may be change this rate
Measured: after surgery at first day, 1th week and 1th month
Change of Cell variation rate
Nitrogen protoxide and oxygen may be change this rate
Measured: at before surgery and 1 week and 1 month after surgery
Change of Hexagonality rate
Nitrogen protoxide and oxygen may be change this rate
Measured: 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
Measured: after surgery at first day, 1th week and 1th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Selim Ozkan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006211
- Sponsor's protocol ID
- Asozkan-4
- Status last verified
- Apr 2017
- First submitted
- 22 Dec 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nitrogen Protoxide + Sevoflurane and Oxygen + Sevoflurane Anesthesia on Corneal Endothelial in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03006211
- Acronym / sponsor ID
- Asozkan-4
- Conditions
- Cornea, Anesthesia; Reaction
- Keywords
- nitrogen protoxide, oxygen, corneal endothelial, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corneal endothal | Active comparator | Other: Nitrogen protoxide, Other: OxygenEvaluate the effects of nitrogen protoxide to corneal endothal and compare with oxygen. |
| Cell density | Active comparator | Other: Nitrogen protoxide, Other: OxygenEvaluate the effects of nitrogen protoxide to Cell density and compare with oxygen. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 40 eyes of 40 pediatric patients who had extraocular surgery under general anesthesia
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrogen protoxide | Other | Cell density, corneal endothal |
| Oxygen | Other | Cell density, corneal endothal |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrogen protoxide and Oxygen in people with Cornea and Anesthesia; Reaction, run by Inonu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of corneal endothal number (time frame: after surgery at first day, 1th week and 1th month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.