Morbid Obesity
Conditions
Keywords
anesthesia, postanesthetic recovery, ventilation, bariatric surgery
Brief summary
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
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.
Interventions
DEVICEProSeal
Patients will be ventilated with PLMA
DEVICESupreme LMA
Patients will be ventilated with SLMA
Sponsors
Azienda Ospedaliera di Padova
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oropharyngeal leak pressure | intraoperatively, up to 3 hours |
Secondary
| Measure | 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 |
| 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 |
| satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale) | day 1 |
Other
| Measure | Time frame |
|---|---|
| insertion time | up to 10 minutes |
Countries
Italy
Contacts
Primary ContactMichele Carron, MD
Backup ContactUlderico Freo, MD
Outcome results
None listed