LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients

NCT ID: NCT06825910

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Airway Management General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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LMA igel group

Group Type ACTIVE_COMPARATOR

LMA igel

Intervention Type DEVICE

adults allocated to the LMA igel group, an LMA igel device will be inserted intraoperatively

LMA protector group

Group Type ACTIVE_COMPARATOR

LMA protector

Intervention Type DEVICE

adults allocated to the LMA protector group, an LMA protector device will be inserted intraoperatively

Interventions

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LMA igel

adults allocated to the LMA igel group, an LMA igel device will be inserted intraoperatively

Intervention Type DEVICE

LMA protector

adults allocated to the LMA protector group, an LMA protector device will be inserted intraoperatively

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nikolopoulou Maria Zozefin

OTHER

Sponsor Role lead

Responsible Party

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Nikolopoulou Maria Zozefin

Anesthesiology Resident at Sismanoglio General Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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SismanoglioGH

Athens, , Greece

Site Status NOT_YET_RECRUITING

SismanoglioGH

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Maria Zozefin Nikolopoulou

Role: CONTACT

+306987389354

Facility Contacts

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Maria Kokolaki

Role: primary

+302132058001

Maria Kokolaki

Role: primary

+302132058001

Other Identifiers

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19242/29.08.24

Identifier Type: -

Identifier Source: org_study_id

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