Comparison of Intra Ocular Pressure After Insertion of the LMA Supreme and LMA Proseal in Pediatric Patients

July 19, 2016 updated by: Zehra Ipek ARSLAN, Kocaeli University

Intra Ocular Pressure After I-gel and Supreme Insertion

The investigators enrolled pediatric patients who are undergoing strabismus surgery. The investigators insert either an I-gel or laryngeal mask airway Supreme and measure the intraocular pressures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We already know that tracheal intubation increased intraocular pressure. We tried to evaluate the change of the intra ocular pressure increase before, during and after insertion the I-gel and LMA Supreme supraglottic airway devices. We enrolled the pediatric patients who are undergoing to strabismus surgery.

Study Type

Interventional

Enrollment (Anticipated)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41900
        • Recruiting
        • Kocaeli University School of Medicine
        • Contact:
        • Principal Investigator:
          • Zehra I ARSLAN, Specialist

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

2 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pediatrics > 2 years
  • pediatrics < 7 years
  • undergoing strabismus surgery

Exclusion Criteria:

  • pediatrics < 2 years
  • pediatrics > 7 years
  • neuromuscular blockage using

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I-gel intra ocular pressure
supraglottic airway device
Device: I-gel
supraglottic airway device without cuff
Active Comparator: LMA Supreme intra ocular pressure
supraglottic airway device
Device: LMA Supreme
supraglottic airway device with cuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intra ocular pressure
Time Frame: 15 minutes
measurement the intra ocular pressure before, during and after insertion of the device
15 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
vomiting
Time Frame: 2 hour
2 hour
bradicardia
Time Frame: 1 hour
1 hour

Collaborators and Investigators

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

Sponsor

Kocaeli 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

July 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimate)

July 24, 2015

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KOU KAEK 2015/14

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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