NCT04915534

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 814 (actual)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postoperative Complications
• Postoperative Pain

Interventions

Type	Name	Description
DEVICE	Ambu® 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.

Timeline

• Start date: 2021-12-06
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2021-06-07
• Last updated: 2024-04-16

Locations

1 site across 1 country: Germany