Gender Specific Differences in Postoperative Sore Throat for Ambu® AuraGain™ Laryngeal Mask

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate gender specific risk factors and the influence of cuff pressure in the occurrence of postoperative sore throat and hoarseness following general anaesthesia using Ambu® AuraGain™ Laryngeal Mask.

Detailed Description
-----------------
The history and physical examinations of all patients scheduled for surgery are screened preoperatively for exclusion criteria. Patient recruitment is conducted by one of the study physicians. After eligibility is confirmed and written informed consent is obtained, enrolled participants are randomized depending on their gender (400 men, 400 women) in a single-blinded manner (patients) 24 hours before the intervention in a 1:1 ratio to low cuff pressure (45 cmH2O) or normal cuff pressure (60 cmH2O). Patient questioning via questionnaire is conducted in postoperative anaesthetic care unit, 24h, 48h and 72h until freedom of symptoms.

Official Title
-----------------
Evaluation of Gender Specific Differences in Postoperative Sore Throat Following General Anaesthesia With Ambu® AuraGain™ Laryngeal Mask

Conditions
-----------------
Postoperative Complications, Postoperative Pain

Intervention / Treatment
-----------------
* Device: Ambu® AuraGain™ Laryngeal Mask (LM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery in ophthalmology under general anaesthesia with laryngeal mask Age > 18 informed written consent Exclusion Criteria: Anticipated difficult airway with indication for awake tracheal intubation Indication for RSI or elevated risk for aspiration; Pregnant or breastfeeding; Age < 18 years; Obesity Out-patient surgery (Geb. 505); Limited mouth opening; Pre-existing hoarseness and sore throat Participant in other studies Unable to provide informed written consent or under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: prospective, randomized, controlled, single-blinded
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Women - low cuff pressure<br>A cuff pressure of 45 cm H2O is used to block the laryngeal mask | Device: Ambu® AuraGain™ Laryngeal Mask (LM)<br>* Depending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness.<br>* Other names: Cuff pressure;|
| Other: Men - low cuff pressure<br>A cuff pressure of 45 cm H2O is used to block the laryngeal mask | Device: Ambu® AuraGain™ Laryngeal Mask (LM)<br>* Depending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness.<br>* Other names: Cuff pressure;|
| Other: Women - normal cuff pressure<br>A cuff pressure of 60 cm H2O is used to block the laryngeal mask | Device: Ambu® AuraGain™ Laryngeal Mask (LM)<br>* Depending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness.<br>* Other names: Cuff pressure;|
| Other: Men - normal cuff pressure<br>A cuff pressure of 60 cm H2O is used to block the laryngeal mask | Device: Ambu® AuraGain™ Laryngeal Mask (LM)<br>* Depending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness.<br>* Other names: Cuff pressure;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender specific differences in sore throat 24 hours postoperative | Comparing the incidence of postoperative sore throat between males and females within the first 24 hours after general anaesthesia with a second-generation Ambu® AuraGain™ Laryngeal Mask for elective, ophthalmological surgery | 24 hours after general anaesthesia (removal of laryngeal mask) | 
| Differences in sore throat 24 hours postoperatively in correlation to cuff pressure | Comparing the incidence of postoperative sore throat within the first 24 hours after general anaesthesia with a second-generation Ambu® AuraGain™ Laryngeal Mask for elective, ophthalmological surgery in correlation to cuff pressure (45 cmH2O and 60 cmH2O) | 24 hours after general anaesthesia (removal of laryngeal mask) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for postoperative sore throat in correlation to gender and cuff pressure | Evaluating the effect of cuff pressure (45 cmH2O vs 60 cmH2O) stratified by gender on the incidence of postoperative sore throat (%). Furthermore, incidence of postoperative sore throat and hoarseness in PACU, at 48 and 72 hours until freedom of symptoms in correlation to gender and cuff pressure. In addition, influence of gender and cuff pressure on duration of pain and pain quality (measured via a pain scale of 0 = no pain, 1 = less than a cold, 2 = like a cold, 3 = more than a cold) will be evaluated. | From end of general anaesthesia (removal of laryngeal mask) until at minimum Day 3. If symptoms persist past Day 3 postoperatively, the maximum observation period is 100 days or until freedom of symptoms (whichever comes first) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative sore throat and hoarseness (POST), laryngeal mask