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

  • STATUS
    Recruiting
  • participants needed
    800
  • sponsor
    Johannes Gutenberg University Mainz
Updated on 9 August 2022
Accepts healthy volunteers

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.

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.

Details
Condition Postoperative Complications, Postoperative Pain
Treatment Ambu® AuraGain™ Laryngeal Mask (LM)
Clinical Study IdentifierNCT04915534
SponsorJohannes Gutenberg University Mainz
Last Modified on9 August 2022

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