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Completed

NCT Number: NCT04915534

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

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.

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Key information

Conditions

Postoperative Complications Hoarseness Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Pain Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Voice Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg-University

Mainz, Rhineland-Palatine, 55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambu® AuraGain™ Laryngeal Mask (LM)

Device

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.

Other names: Cuff pressure

Primary outcomes

  1. Gender specific differences in sore throat 24 hours postoperative

    Time frame: 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

  2. Differences in sore throat 24 hours postoperatively in correlation to cuff pressure

    Time frame: 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 outcomes

  1. Risk factors for postoperative sore throat in correlation to gender and cuff pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Acronym: LadyLAMA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2021
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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