LMA Protector vs I-Gel in Low-Flow Anesthesia for Laparoscopic Cholecystectomy

NCT07707440 | Completed

• 1 other identifier: FSM KAEK-2020/79
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized study aims to compare two second-generation supraglottic airway devices (SGAs), the I-Gel and the laryngeal mask airway (LMA) Protector, in patients undergoing laparoscopic cholecystectomy under low-flow desflurane anesthesia. The study evaluates the devices in terms of respiratory mechanics (dynamic compliance, peak inspiratory pressure, plateau pressure, and airway resistance), non-invasive perfusion parameters (oxygen reserve index, perfusion index, and pleth variability index), hemodynamic stability, ease of insertion, oropharyngeal leak pressure, and postoperative complication rates.

Conditions

Laparoscopic Cholecystectomy; Anesthesia, General

Keywords

Low-Flow Anesthesia; Supraglottic Airway Device; I-Gel; LMA Protector; Respiratory Mechanics

Outcome Measures

Primary Outcomes (1)

• Dynamic Lung Compliance (Cdyn)

  Dynamic compliance of the respiratory system, calculated automatically by the ventilator as tidal volume divided by (peak inspiratory pressure minus positive end-expiratory pressure).

  Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.

Secondary Outcomes (3)

• Peak Inspiratory Pressure (PIP)

  Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.

• Plateau Pressure (Pplateau)

  Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.

• Airway Resistance

  Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.

Study Arms (2)

Group I: I-Gel

EXPERIMENTAL

Patients managed with the I-Gel supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy.

Device: I-Gel supraglottic airway

Group P: LMA Protector

EXPERIMENTAL

Patients managed with the LMA Protector supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy.

Device: LMA Protector supraglottic airway

Interventions

I-Gel supraglottic airway DEVICE

Placement of an appropriate size of i-gel supraglottic airway device for airway management during general anesthesia. Anesthesia maintenance is provided with desflurane in a fresh gas flow of 1 L/min (low-flow anesthesia).

Also known as: i-gel

Group I: I-Gel

LMA Protector supraglottic airway DEVICE

Placement of an appropriate size of LMA Protector supraglottic airway device for airway management during general anesthesia. Anesthesia maintenance is provided with desflurane in a fresh gas flow of 1 L/min (low-flow anesthesia).

Also known as: Laryngeal Mask Airway Protector

Group P: LMA Protector

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years
• American Society of Anesthesiologists (ASA) physical status I or II
• Scheduled for elective laparoscopic cholecystectomy

You may not qualify if:

• Known or predicted difficult airway or history of difficult intubation
• Body Mass Index (BMI) greater than 35 kg/m²
• High risk of gastroesophageal reflux or aspiration
• Severe cardiac, respiratory, renal, or hepatic disease
• Pregnancy
• Patient refusal to participate

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead
• Masimo Corporation: collaborator

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)