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

Intra Ocular Pressure Clinical Trial

Official title:

Intra Ocular Pressure After I-gel and Supreme Insertion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02508181
• Other study ID #: KOU KAEK 2015/14
• Status: Recruiting
• Phase: Phase 4
• First received: July 22, 2015
• Last updated: July 19, 2016
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

Inclusion Criteria:

• pediatrics > 2 years

• pediatrics < 7 years

• undergoing strabismus surgery

Exclusion Criteria:

• pediatrics < 2 years

• pediatrics > 7 years

• neuromuscular blockage using

Related Conditions & MeSH terms

• Intra Ocular Pressure

Intervention

Device:
• I-gel
supraglottic airway device without cuff
• LMA Supreme
supraglottic airway device with cuff

Locations

Country	Name	City	State
Turkey	Kocaeli University School of Medicine	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra ocular pressure	measurement the intra ocular pressure before, during and after insertion of the device	15 minutes
Secondary	vomiting		2 hour
Secondary	bradicardia		1 hour