Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeres

Study Overview
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Brief Summary
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The LMA Proseal and LMA Supreme are the third generation of LMA with potential advantages over the classic LMA.Several publications have reported the successful, safe use of Laryngeal Mask Airway devices in patients undergoing laparoscopic surgery. However, there have been no studies that have examined the application of LMA in patients during lateral positioned laparoscopic surgery. The aim of this study is to observe the safety and efficacy when LMA Proseal and LMA Supreme used in lateral positioned laparoscopic surgery under general anesthesia.

Detailed Description
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We undertook a single-blind, parallel-group, randomized controlled trial.The patients were randomized to either LMA Proseal group or LMA Supreme group by computer generated allocation. The patients were scheduled for elective lateral positioned laparoscopic surgery, such as laparoscopic radical nephrectomy, laparoscopic renal cyst decortication (LRCD) or laparoscopic adrenalectomy.Inclusion criteria for the patients were: Aged>18 years, ASA physical status grade I - Ⅲ and body mass index ≤30 kg.m-2. Exclusion criteria were: anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.

Official Title
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Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeries

Conditions
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Urologic Surgical Procedures

Intervention / Treatment
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* Device: LMA Proseal
* Device: LMA Supreme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients belong to ASA physical status grade I and Ⅲ, aged above 18 years and body weight less than 30 kg/m2,who underwent elective laparoscopic urology surgery in the lateral position. Exclusion Criteria: The patients with anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMA Proseal group<br>The patients were randomly allocated to two groups by using computer-generated numbers.In LMA Prosealgroup,LMA Proseal was inserted into each patient after anesthesia induction. | Device: LMA Proseal<br>* After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium,LMA Proseal was inserted and cuff inflated in each group.<br>|
| Experimental: LMA Supreme group<br>The patients were randomly allocated to two groups by using computer-generated numbers.In LMA Supreme group,LMA Supreme was inserted into each patient after anesthesia induction. | Device: LMA Supreme<br>* After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium ，LMA Supreme was inserted and cuff inflated in each group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oropharyngeal seal pressure between LMA Proseal group and LMA Supreme group | The equilibrating airway pressure was recorded when an audible leak occurred over the mouth. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilatory efficiency scores for the LMAs |  | intraoperative | 
| Adverse effects in two groups | The adverse effects including regurgitation,hypoxemia,dysphonia,blood stained after LMA removal, and postoperative sore throat. | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal Mask Airway, lateral position, laparoscopic surgery