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ClinicalTrials.gov ID

NCT06825910

Lead Sponsor

Nikolopoulou Maria ZozefinOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

Apr 27, 2026Actual

Start Date

Feb 1, 2025Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

Official Title

Laryngeal Mask Airway I-Gel and Laryngeal Mask Airway Protector for Minor Urological Procedures Under General Anesthesia in Adult Patients: A Randomized Comparative Study

Brief Summary

This will be a randomized comparative study comparing the two supraglottic devices i-gel and Protector, intraoperatively, during minor urological procedures under general anesthesia in adult patient.

Detailed Description

This randomized comparative study aims to evaluate the effectiveness, safety, and unwanted effects of two laryngeal mask airway devices, the iGel and the Protector. The study will involve adult patients during minor urological procedures under general anesthesia. Participants will be divided into two groups: in one group will be inserted the iGel laryngeal mask airway, while in the other group will be inserted the Protector laryngeal mask airway.

• Airway Management
• General Anesthesia

• LMA igel
• LMA protector

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

• ASA I-II
• Patients older than 18 years
• Procedures in supine and lithotomy position

Exclusion Criteria:

• Tumors or anatomical anomalies of the upper airway
• Known history of difficult intubation
• Limited mouth opening less than 2cm
• Decreased compliance of the lungs or the thoracic cage
• Need of mechanical ventilation after the surgery

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Nikolopoulou Maria ZozefinOTHER

dnths-anaisth@sismanoglio.gr+302132058001