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

Phase 4

• Conditions: Intra Ocular Pressure
• Interventions: Device: I-gel; Device: LMA Supreme

• Registration Number: NCT02508181
• Lead Sponsor: Kocaeli University

Brief Summary

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.

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-24
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-20
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
I-gel intra ocular pressure	I-gel	supraglottic airway device
LMA Supreme intra ocular pressure	LMA Supreme	supraglottic airway device

Primary Outcome Measures

Name	Time	Method
intra ocular pressure	15 minutes	measurement the intra ocular pressure before, during and after insertion of the device

Secondary Outcome Measures

Name	Time	Method
bradicardia	1 hour
vomiting	2 hour

Trial Locations

Locations (1)

Kocaeli University School of Medicine; 🇹🇷 Kocaeli, Turkey