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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women - low cuff pressure | Other | A cuff pressure of 45 cm H2O is used to block the laryngeal mask |
|
| Men - low cuff pressure | Other | A cuff pressure of 45 cm H2O is used to block the laryngeal mask |
|
| Women - normal cuff pressure | Other | A cuff pressure of 60 cm H2O is used to block the laryngeal mask |
|
| Men - normal cuff pressure | Other | A cuff pressure of 60 cm H2O is used to block the laryngeal mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Biological gender (gender specific physiology of the Larynx)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg-University | Mainz | Rhineland-Palatine | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25061426 | Background | 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. | |
| 35105650 | Derived | Epp K, Przybylski U, Luz C, Kriege M, Wittenmeier E, Schmidtmann I, Pirlich N. Evaluation of gender differences in postoperative sore throat and hoarseness following the use of Ambu AuraGain laryngeal mask: the randomised controlled LadyLAMA trial study protocol. BMJ Open. 2022 Jan 31;12(1):e056465. doi: 10.1136/bmjopen-2021-056465. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010149 | Pain, Postoperative |
| D006685 | Hoarseness |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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prospective, randomized, controlled, single-blinded
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Patients are allocated to the cuff pressure groups via block randomization
|
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| 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) |
| D012816 | Signs and Symptoms |
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |