Anesthesia, General, Laparoscopic Cholecystectomy
Conditions
Keywords
Low-Flow Anesthesia, Supraglottic Airway Device, I-Gel, LMA Protector, Respiratory Mechanics
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.
Detailed description
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.
Interventions
DEVICEI-Gel supraglottic airway
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).
DEVICELMA Protector supraglottic airway
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).
Sponsors
Fatih Sultan Mehmet Training and Research Hospital
Masimo Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Lung Compliance (Cdyn) | 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
| Measure | Time frame | Description |
|---|---|---|
| Peak Inspiratory Pressure (PIP) | 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. |
| Plateau Pressure (Pplateau) | 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. |
| Airway Resistance | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed