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NCT Number: NCT07707440

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

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.

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Key information

Conditions

Laparoscopic Cholecystectomy Anesthesia, General

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

About this study

Sixty-two patients (ASA I-II, aged 18-65 years) scheduled for elective laparoscopic cholecystectomy were randomized into two groups: Group I (I-Gel) and Group P (LMA Protector). General anesthesia induction was standardized, and maintenance was provided with desflurane at a fresh gas flow of 1 L/min to achieve low-flow anesthesia. Peak inspiratory pressure (PIP), plateau pressure (Pplato), dynamic compliance (Cdyn), and airway resistance were recorded at six distinct intraoperative time points: 5 minutes after SGA insertion (T1), 1 minute after pneumoperitoneum insufflation (T2), 1 minute after the 30-degree reverse Trendelenburg position (T3), 10 minutes after insufflation (T4), 1 minute after desufflation (T5), and immediately before SGA removal (T6). Oropharyngeal leak pressure (OLP) was measured after insertion and before removal. Postoperative complications such as sore throat, cough, hoarseness, dysphagia, and nausea-vomiting were monitored postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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).

Other names: 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).

Other names: Laryngeal Mask Airway Protector

Primary outcomes

  1. Dynamic Lung Compliance (Cdyn)

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

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

Secondary outcomes

  1. Peak Inspiratory Pressure (PIP)

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

    Maximum airway pressure generated during the inspiratory phase, monitored to assess airway dynamics under general anesthesia.

  2. Plateau Pressure (Pplateau)

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

    Pressure applied to the small airways and alveoli during a period of zero gas flow, monitored to assess risk of barotrauma.

  3. Airway Resistance

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

    The resistance of the respiratory tract to airflow during mechanical ventilation, calculated using peak and plateau pressures.

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Collaborators

  • Masimo Corporation

Registry information

Official study title

Comparison of LMA Protector and I-Gel Use in Low-Flow Anesthesia for Laparoscopic Cholecystectomy: A Prospective Randomized Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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