Clinical trial NCT04915534: Gender Specific Differences in Postoperative Sore Throat for Ambu® AuraGain™ Laryngeal Mask
Official title: Evaluation of Gender Specific Differences in Postoperative Sore Throat Following General Anaesthesia With Ambu® AuraGain™ Laryngeal Mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Postoperative Pain
Keywords: postoperative sore throat and hoarseness (POST)
laryngeal mask
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 814
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: prospective, randomized, controlled, single-blinded
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Gender specific differences in sore throat 24 hours postoperative
timeFrame: 24 hours after general anaesthesia (removal of laryngeal mask)
measure: Differences in sore throat 24 hours postoperatively in correlation to cuff pressure
timeFrame: 24 hours after general anaesthesia (removal of laryngeal mask)
Secondary outcomes:
measure: Risk factors for postoperative sore throat in correlation to gender and cuff pressure
timeFrame: 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)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg-University
state: Rhineland-Palatine
Study officials:
References:
citation: Jaensson M, Gupta A, Nilsson U. Gender differences in sore throat and hoarseness following endotracheal tube or laryngeal mask airway: a prospective study. BMC Anesthesiol. 2014 Jul 19;14:56. doi: 10.1186/1471-2253-14-56. eCollection 2014.
citation: Epp K, Przybylski U, Luz C, Kriege M, Wittenmeier E, Schmidtmann I, Pirlich N. Evaluation of gender differences in postoperative sore throat and hoarseness following the use of Ambu AuraGain laryngeal mask: the randomised controlled LadyLAMA trial study protocol. BMJ Open. 2022 Jan 31;12(1):e056465. doi: 10.1136/bmjopen-2021-056465.