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

Postoperative Pain Clinical Trial

— LadyLAMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04915534
• Other study ID #: 13715
• Status: Completed
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: April 2024
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 814
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis
• Postoperative Complications
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg-University	Mainz	Rhineland-Palatine

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Jaensson M, Gupta A, Nilsson U. Gender differences in sore throat and hoarseness following endotracheal tube or laryngeal mask airway: a prospective study. BMC Anesthesiol. 2014 Jul 19;14:56. doi: 10.1186/1471-2253-14-56. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gender specific differences in sore throat 24 hours postoperative	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	24 hours after general anaesthesia (removal of laryngeal mask)
Primary	Differences in sore throat 24 hours postoperatively in correlation to cuff pressure	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)	24 hours after general anaesthesia (removal of laryngeal mask)
Secondary	Risk factors for postoperative sore throat in correlation to gender and cuff pressure	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.	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)