Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients

Study Overview
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Brief Summary
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The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak pressure. The investigators also studied their relative ease of insertion, time to insertion and complications of use as secondary outcome measures.

Detailed Description
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A total of 105 patients scheduled for elective gynaecological laparoscopic procedures in our Inonu University Medical Faculty Hospital were recruited.They were equally randomized into three groups: PLMA, supreme and i-gel groups. All three devices were compared with regard to oropharyngeal leak pressure, number and duration of insertion attempts and complications of airway. Oropharyngeal leak pressure will evaluate including to start,trendelenburg and postoperative at period. Fiberoptic evaluation of the LMA's position were performed after successful insertion and determination of the airway pressures. After one hour patients were evaluated by a blinded independent observer for postoperative complications ( sore throat, dysphonia and dysphagia).

Official Title
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Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients Undergoing Gynaecological Laparoscopic Surgery With Oropharyngeal Leak Pressure

Conditions
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Airway Complication of Anaesthesia

Intervention / Treatment
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* Device: PROSEAL LMA
* Device: SUPREMA LMA
* Device: I-GEL LMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18- 60 YEARS Exclusion Criteria: ASA 3-4 patients BMI 40

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ProSeal LMA<br>Supraglottic airway device | Device: PROSEAL LMA<br>* Size 3,4 or 5 supraglottic device with orogastric drainage tube<br>|
| Active Comparator: suprema LMA<br>Supraglottic airway device | Device: SUPREMA LMA<br>* Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube<br>|
| Active Comparator: I-gel LMA<br>Supraglottic airway device | Device: I-GEL LMA<br>* Size 3,4,5 disposable supraglottic device with noninflatable cuff<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of oropharyngeal leak pressure | During intraoperative period, oropharyngeal leak pressure was measured at three times (10min, 30 min, and 45 min after insertion of devices) | 10min, 30 min ,45 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| easiness of insertion of the device | During insertion, easiness of the devices were evaluated by a scale | 2 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway management