Laparoscopic CholecystectomyNCT07707440
LMA Protector vs I-Gel in Low-Flow Anesthesia for Laparoscopic Cholecystectomy
A study testing I-Gel supraglottic airway and LMA Protector supraglottic airway in people with Laparoscopic Cholecystectomy and Anesthesia, General, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Anesthesia, General
- What is being tested?
- I-Gel supraglottic airway and LMA Protector supraglottic airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective laparoscopic cholecystectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34752
About this study
Official title: 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.
Read the 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.
- Conditions
- Laparoscopic Cholecystectomy, Anesthesia, General
- Being tested
- I-Gel supraglottic airway, LMA Protector supraglottic airway
- Keywords
- Low-Flow Anesthesia, Supraglottic Airway Device, I-Gel, LMA Protector, Respiratory Mechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-Gel supraglottic airwayDevice
Also called i-gel
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).
LMA Protector supraglottic airwayDevice
Also called Laryngeal Mask Airway Protector
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).
| Study group | Role | What they receive |
|---|---|---|
| Group I: I-Gel | Experimental | Patients managed with the I-Gel supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy. Receives: 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. Receives: Device: LMA Protector supraglottic airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
Maximum airway pressure generated during the inspiratory phase, monitored to assess airway dynamics under general anesthesia.
Measured: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Plateau Pressure (Pplateau)
Pressure applied to the small airways and alveoli during a period of zero gas flow, monitored to assess risk of barotrauma.
Measured: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Airway Resistance
The resistance of the respiratory tract to airflow during mechanical ventilation, calculated using peak and plateau pressures.
Measured: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jul 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Principal investigator, Ahmet Emre Akın, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707440
- Sponsor's protocol ID
- FSM KAEK-2020/79
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of LMA Protector and I-Gel Use in Low-Flow Anesthesia for Laparoscopic Cholecystectomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07707440
- Acronym / sponsor ID
- FSM KAEK-2020/79
- Conditions
- Laparoscopic Cholecystectomy, Anesthesia, General
- Keywords
- Low-Flow Anesthesia, Supraglottic Airway Device, I-Gel, LMA Protector, Respiratory Mechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: I-Gel | Experimental | Device: I-Gel supraglottic airwayPatients managed with the I-Gel supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy. |
| Group P: LMA Protector | Experimental | Device: LMA Protector supraglottic airwayPatients managed with the LMA Protector supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-Gel supraglottic airwayAlso: i-gelPlacement 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). | Device | Group I: I-Gel |
| LMA Protector supraglottic airwayAlso: Laryngeal Mask Airway ProtectorPlacement 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). | Device | Group P: LMA Protector |
Primary outcome
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).
3 secondary outcomes
Peak Inspiratory Pressure (PIP)
Time frame: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Plateau Pressure (Pplateau)
Time frame: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Airway Resistance
Time frame: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-Gel supraglottic airway and LMA Protector supraglottic airway in people with Laparoscopic Cholecystectomy and Anesthesia, General, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Lung Compliance (Cdyn) (time frame: Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.