Laryngeal Masks for Bariatric Surgery

Study Overview
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Brief Summary
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Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.

Detailed Description
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The study will investigate two types of LMA devices endowed of different constructive features. The two devices share common features as far as providing access to the stomach and reducing morbidity of the upper airway. The two device differ in regard to ease of insertion and sealing of the airway and these features are particularly important in the obese patient.

Official Title
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A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.

Conditions
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Morbid Obesity

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class I-III candidates to bariatric surgery Exclusion Criteria: uncontrolled psychiatric symptomatology known or presumed pregnancy history of surgery on the airway or esophagus gastroesophageal reflux

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLMA<br>ProSeal | Device: ProSeal<br>* Patients will be ventilated with PLMA<br>|
| Experimental: SLMA<br>Supreme LMA | Device: Supreme LMA<br>* Patients will be ventilated with SLMA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oropharyngeal leak pressure |  | intraoperatively, up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total anesthetic and analgesic drug dosages |  | intraoperatively and postoperatively, up to 24 hours from end of surgery | 
| pulse oximetry saturation |  | intraoperatively and postoperatively, up to 24 hours from end of surgery | 
| time to post-anesthetic discharge scoring system (PADSS) > 8 |  | in PACU up 72 hours | 
| EKG monitoring |  | postoperatively up to 72 hours | 
| satisfaction of the surgeon (ad hoc questionnaire) |  | day 1 | 
| satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale) |  | day 1 | 
| gastric distension |  | intraoperatively up to 3 hours | 
| levels of pain and nausea (Visual Analogue Scale) |  | postoperatively up to 24 hours | 
| metilen's blue |  | before end of surgery up to 3 hours | 
| total dosage of analgesic and antihemetic drugs |  | intra and postoperatively up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia, postanesthetic recovery, ventilation, bariatric surgery