Gutenberg Open Science: 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

Please use this identifier to cite or link to this item: http://doi.org/10.25358/openscience-8646

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DC Field	Value	Language
dc.contributor.author	Epp, Katharina	-
dc.contributor.author	Przybylski, Uli	-
dc.contributor.author	Luz, Carla	-
dc.contributor.author	Kriege, Marc	-
dc.contributor.author	Wittenmeier, Eva	-
dc.contributor.author	Schmidtmann, Irene	-
dc.contributor.author	Pirlich, Nina	-
dc.date.accessioned	2023-01-26T08:27:58Z	-
dc.date.available	2023-01-26T08:27:58Z	-
dc.date.issued	2022	-
dc.identifier.uri	https://openscience.ub.uni-mainz.de/handle/20.500.12030/8662	-
dc.description.abstract	Introduction Postoperative sore throat (POST) is a comparatively minor but very common side effect of general anaesthesia with a supraglottic airway device. The patient considers these side effects a mirror of the quality of anaesthesia. The aims of this study are to evaluate gender-specific differences in the incidence of POST and to assess whether the effects of known risk factors vary between genders. Methods and analysis The LadyLAMA trial is a single-centre, patient-blinded, randomised controlled trial. Consecutive patients requiring ophthalmological surgery under general anaesthesia with a second generation Ambu AuraGain laryngeal mask are randomly allocated to either cuff pressure of 45 cmH2O or cuff pressure of 60 cmH2O. We estimate the difference in POST between the genders at 20% and we hypothesised that a reduction of cuff pressure would reduce POST by 10%. A total of 800 patients will be recruited, with each subgroup including 200 patients to achieve 80% power for detecting a difference at the 5% significance level. Primary endpoints are gender differences in the incidence of POST within 24 hours postoperatively, as well as comparison of cuff pressure 45 cmH2O to 60 cmH2O with respect to POST. The main secondary objective is the effect of cuff pressure on POST stratified by gender. Further secondary endpoints are gender-specific differences in POST and hoarseness in postanaesthesia care unit (PACU) at 48 and 72 hours (or until freedom of discomfort). The parameter cuff pressure serves as key-secondary endpoint.	en_GB
dc.description.sponsorship	Gefördert durch die Deutsche Forschungsgemeinschaft (DFG) - Projektnummer 491381577	de
dc.language.iso	eng	de
dc.rights	CC BY-NC	*
dc.rights.uri	https://creativecommons.org/licenses/by-nc/4.0/	*
dc.subject.ddc	610 Medizin	de_DE
dc.subject.ddc	610 Medical sciences	en_GB
dc.title	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	en_GB
dc.type	Zeitschriftenaufsatz	de
dc.identifier.doi	http://doi.org/10.25358/openscience-8646	-
jgu.type.contenttype	Scientific article	de
jgu.type.dinitype	article	en_GB
jgu.type.version	Published version	de
jgu.type.resource	Text	de
jgu.organisation.department	FB 04 Medizin	de
jgu.organisation.number	2700	-
jgu.organisation.name	Johannes Gutenberg-Universität Mainz	-
jgu.rights.accessrights	openAccess	-
jgu.journal.title	BMJ Open	de
jgu.journal.volume	12	de
jgu.journal.issue	1	de
jgu.pages.alternative	e056465	de
jgu.publisher.year	2022	-
jgu.publisher.name	BMJ Publishing Group	de
jgu.publisher.place	London	de
jgu.publisher.issn	2044-6055	de
jgu.organisation.place	Mainz	-
jgu.subject.ddccode	610	de
jgu.publisher.doi	10.1136/bmjopen-2021-056465	de
jgu.organisation.ror	https://ror.org/023b0x485	-
jgu.subject.dfg	Lebenswissenschaften	de
Appears in collections:	DFG-491381577-G

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