protocolSection identificationModule nctId: NCT06292065, orgStudyIdInfo id: Project ID 6171, briefTitle: Gastric Ultrasound To Assess Gastric Contents In Patients On Semaglutide Therapy, acronym: GUST, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Nils Vlaeminck, class: OTHER, descriptionModule briefSummary: Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1-RA) such as semaglutide (Ozempic™, Rybelsus™, Wegovy™) were first introduced as a therapeutic agent for type 2 diabetes mellitus but they are being increasingly used to target weight loss in obesity.One of the mechanisms by which weight loss is achieved, is increased satiety and significantly delayed gastric emptying. Tachyphylaxis for this effect has been reported with chronic use of long acting GLP-1-RA (e.g. semaglutide) but this was based on the paracetamol absorption technique or 13C breath test. Recent clinical data suggests semaglutide use does increase perioperative gastric content.This creates uncertainty for anaesthetists who are, anecdotally, more frequently faced with patients who may or may not have full stomachs despite adhering to conventional fasting guidelines.To address this issue the American Society of Anesthesiologists (ASA) has recently released guidelines in which it advises to hold GLP-1-RA for one day (if administered daily) or one week (if administered weekly).However, these recommendations are based on sparse empirical evidence and they do not necessarily follow from the known pharmacokinetic properties of these drugs. Typically, GLP-1-RA are administered in increasing doses over several weeks until a therapeutic steady state is achieved. Meanwhile the elimination half-life of e.g. semaglutide is 7 days. This means that holding semaglutide for one day or even one week might not be enough to attenuate its therapeutic effect of delayed gastric emptying. On the other hand if semaglutide were to be held for e.g. 5 terminal half-lifes, this would mean an unpractical 5 weeks during which glycemic control may be worsened and after which semaglutide doses would have to be incrementally increased again. Besides, hyperglycaemia secondary to semaglutide cessation can also delay gastric emptying.Further confounding the assessment of these patients there can be 'background' delayed gastric emptying in diabetic patients and more pronounced delayed gastric emptying in patients recently started on GLP-1-RA. The presence of gastro-intestinal symptoms (nausea, vomiting, dyspepsia, abdominal distension) might offer clinical information regarding increased gastric residue in this population.Gastric ultrasound is a point-of-care clinical and research tool that has steadily gained popularity to assess gastric content in patients not compliant with fasting rules or with certain comorbidities. Clinical decisions can be made based on the visualised content (e.g. solids, fluids or nothing) or through calculation of gastric volume by measuring antral circumference. In this study the investigators will examine gastric contents in patients who are taking semaglutide and in patients who are not. The investigators will then evaluate whether there is a difference in the incidence of full stomachs and whether gastric ultrasound influenced the anaesthetic plan of the treating anaesthetist., conditionsModule conditions: Gastroparesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 45 patients on semaglutide therapy will be included together with 45 age, BMI and diabetes status matched controls., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Point-of-care gastric ultrasound, outcomesModule primaryOutcomes measure: Prevalence of full stomach, secondaryOutcomes measure: Frequency of changes to the anaesthetic plan, secondaryOutcomes measure: Calculated gastric content, secondaryOutcomes measure: Prevalence of solid gastric content, secondaryOutcomes measure: Association between fasting time for solids and 'full stomach', secondaryOutcomes measure: Association between fasting time for liquids and 'full stomach', secondaryOutcomes measure: Frequency of perioperative aspiration, secondaryOutcomes measure: Prevalence of gastric symptoms, secondaryOutcomes measure: Association between nausea and 'full stomach', secondaryOutcomes measure: Association between vomiting and 'full stomach', secondaryOutcomes measure: Association between dyspepsia and 'full stomach', secondaryOutcomes measure: Association between abdominal distension and 'full stomach', secondaryOutcomes measure: association between semaglutide dose and calculated gastric content, secondaryOutcomes measure: association between semaglutide dose and 'full stomach', secondaryOutcomes measure: Association between frequency of semaglutide administration and calculated gastric content, secondaryOutcomes measure: Association between frequency of semaglutide administration and 'full stomach', secondaryOutcomes measure: Association between duration of semaglutide therapy and calculated gastric content, secondaryOutcomes measure: Association between duration of semaglutide therapy at current dose and calculated gastric content, secondaryOutcomes measure: Association between duration of semaglutide therapy and 'full stomach', secondaryOutcomes measure: Association between duration of semaglutide therapy at current dose and 'full stomach', secondaryOutcomes measure: Association between duration of cessation of semaglutide and calculated gastric content, secondaryOutcomes measure: Association between duration of cessation of semaglutide and 'full stomach', secondaryOutcomes measure: Association between preoperative blood glucose levels and calculated gastric content, secondaryOutcomes measure: Association between preoperative blood glucose levels and 'full stomach', secondaryOutcomes measure: Association between HbA1c levels and calculated gastric content, secondaryOutcomes measure: Association between HbA1c levels and 'full stomach', secondaryOutcomes measure: Association between time since onset of diabetes mellitus and calculated gastric content, secondaryOutcomes measure: Association between time since onset of diabetes mellitus and 'full stomach', eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Antwerp University Hospital, status: RECRUITING, city: Edegem, state: Antwerp, zip: 2650, country: Belgium, contacts name: Nils Vlaeminck, role: CONTACT, phone: 038215865, email: nils.vlaeminck@uza.be, contacts name: Vera Saldien, role: CONTACT, phone: 038214788, email: vera.saldien@uza.be, geoPoint lat: 51.15662, lon: 4.44504, hasResults: False