LMA Protector vs I-Gel in Low-Flow Anesthesia for Laparoscopic Cholecystectomy
11. juli 2026 oppdatert av: Ahmet Emre Akın, Fatih Sultan Mehmet Training and Research Hospital
Comparison of LMA Protector and I-Gel Use in Low-Flow Anesthesia for Laparoscopic Cholecystectomy: A Prospective Randomized Study
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
62
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Istanbul, Tyrkia (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Group I: I-Gel
Patients managed with the I-Gel supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy.
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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).
Andre navn:
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Eksperimentell: Group P: LMA Protector
Patients managed with the LMA Protector supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy.
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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).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Dynamic Lung Compliance (Cdyn)
Tidsramme: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Dynamic compliance of the respiratory system, calculated automatically by the ventilator as tidal volume divided by (peak inspiratory pressure minus positive end-expiratory pressure).
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Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Peak Inspiratory Pressure (PIP)
Tidsramme: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Maximum airway pressure generated during the inspiratory phase, monitored to assess airway dynamics under general anesthesia.
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Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Plateau Pressure (Pplateau)
Tidsramme: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Pressure applied to the small airways and alveoli during a period of zero gas flow, monitored to assess risk of barotrauma.
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Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Airway Resistance
Tidsramme: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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The resistance of the respiratory tract to airflow during mechanical ventilation, calculated using peak and plateau pressures.
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Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Samarbeidspartnere og etterforskere
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Samarbeidspartnere
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2020
Primær fullføring (Faktiske)
31. oktober 2020
Studiet fullført (Faktiske)
31. oktober 2020
Datoer for studieregistrering
Først innsendt
5. juli 2026
Først innsendt som oppfylte QC-kriteriene
11. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- FSM KAEK-2020/79
Plan for individuelle deltakerdata (IPD)
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NEI
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