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The purpose of this study is to determine whether the leak pressure of the recently introduced laryngeal mask airway, Ambu AuraGain performs superior to the established laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak pressure is the pressure at which a gas leaks around the airway, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambu AuraGain (Group A) | Experimental | Laryngeal mask Ambu AuraGain will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure |
|
| LMA Supreme (Group S) | Active Comparator | Laryngeal mask Supreme will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambu AuraGain | Device |
| ||
| LMA Supreme |
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal leak pressure (OLP) for each airway device after insertion | OLP is defined as 'the anesthesia circuit pressure at which a gas leak occurs around the SAD'. | Within 2-3 minutes after laryngeal mask insertion before start of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Phrayngolaryngeal complications | Complications like sore throat, dysphonia, dysphagia | at 1 hr, 2hr and 24 hrs after the surgery |
| Postoperative nausea and vomiting (PONV) | PONV in the post anesthesia care unit (PACU)- PONV will be recorded as only None for No PONV and Yes for present. Severity grading will not be recorded. |
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Inclusion Criteria
ASA physical status I to III Adults more above 18 years Ambulatory surgeries under general anesthesia in supine position requiring laryngeal masks- Knee arthroscopies, bladder tumour resections, hand, eye and general surgical procedures Muscle relaxant not required
Exclusion Criteria
Reduced mouth opening less than 2.5 cms Recent upper respiratory tract infection and sore throat in last 2 weeks Contraindications to laryngeal mask use as in morbid obesity- BMI more than 40 and severe symptomatic esophageal reflux disease
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| Name | Affiliation | Role |
|---|---|---|
| David T Wong, MD | Uinversity Health Network (UHN), Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29582360 | Derived | Wong DT, Ooi A, Singh KP, Dallaire A, Meliana V, Lau J, Chung F, Singh M, Wong J. Comparison of oropharyngeal leak pressure between the Ambu(R) AuraGain and the LMA(R) Supreme supraglottic airways: a randomized-controlled trial. Can J Anaesth. 2018 Jul;65(7):797-805. doi: 10.1007/s12630-018-1120-4. Epub 2018 Mar 26. |
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|
| at 1 hr, 2hr and 24 hrs after the surgery |
| Satisfaction of patient and the anesthesiologist with the device | Patient satisfaction (5 point scale)- 0 for very dissatisfied to 5 for very satisfied Anesthesiologist satisfaction scale- Low, Moderate and High | After 1hr in the post anesthesia care unit (PACU) |