Postoperative Complications, Postoperative Pain
Conditions
Keywords
postoperative sore throat and hoarseness (POST), laryngeal mask
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.
Interventions
DEVICEAmbu® AuraGain™ Laryngeal Mask (LM)
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.
Sponsors
Johannes Gutenberg University Mainz
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients are allocated to the cuff pressure groups via block randomization
Intervention model description
prospective, randomized, controlled, single-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gender specific differences in sore throat 24 hours postoperative | 24 hours after general anaesthesia (removal of laryngeal mask) | 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 |
| Differences in sore throat 24 hours postoperatively in correlation to cuff pressure | 24 hours after general anaesthesia (removal of laryngeal mask) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors for postoperative sore throat in correlation to gender and cuff pressure | 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) | 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. |
Countries
Germany
Outcome results
None listed