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

Not Applicable

Completed

• Conditions: Postoperative Pain; Postoperative Complications
• Interventions: Device: Ambu® AuraGain™ Laryngeal Mask (LM)

• Registration Number: NCT04915534
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-07
• Study Start: 2021-12-06
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-14
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 814

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Women - low cuff pressure	Ambu® AuraGain™ Laryngeal Mask (LM)	A cuff pressure of 45 cm H2O is used to block the laryngeal mask
Men - normal cuff pressure	Ambu® AuraGain™ Laryngeal Mask (LM)	A cuff pressure of 60 cm H2O is used to block the laryngeal mask
Men - low cuff pressure	Ambu® AuraGain™ Laryngeal Mask (LM)	A cuff pressure of 45 cm H2O is used to block the laryngeal mask
Women - normal cuff pressure	Ambu® AuraGain™ Laryngeal Mask (LM)	A cuff pressure of 60 cm H2O is used to block the laryngeal mask

Primary Outcome Measures

Name	Time	Method
Gender specific differences in sore throat 24 hours postoperative	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
Differences in sore throat 24 hours postoperatively in correlation to cuff pressure	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 Outcome Measures

Name	Time	Method
Risk factors for postoperative sore throat in correlation to gender and cuff pressure	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.

Trial Locations

Locations (1)

Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg-University; 🇩🇪 Mainz, Rhineland-Palatine, Germany