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

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Postoperative Pain; Postoperative Complications

Treatments: Device: Ambu® AuraGain™ Laryngeal Mask (LM)

Study type: Interventional

Funder types: Other

Identifiers

NCT04915534

13715

Details and patient eligibility

About

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.

Full 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.

Enrollment: 814 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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814 participants in 4 patient groups

Women - low cuff pressure

Other group

Description:

A cuff pressure of 45 cm H2O is used to block the laryngeal mask

Treatment:

Device: Ambu® AuraGain™ Laryngeal Mask (LM)

Men - low cuff pressure

Other group

Description:

A cuff pressure of 45 cm H2O is used to block the laryngeal mask

Treatment:

Device: Ambu® AuraGain™ Laryngeal Mask (LM)

Women - normal cuff pressure

Other group

Description:

A cuff pressure of 60 cm H2O is used to block the laryngeal mask

Treatment:

Device: Ambu® AuraGain™ Laryngeal Mask (LM)

Men - normal cuff pressure

Other group

Description:

A cuff pressure of 60 cm H2O is used to block the laryngeal mask

Treatment:

Device: Ambu® AuraGain™ Laryngeal Mask (LM)