Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-04-07 @ 12:06 PM
Study NCT ID:
NCT06263595
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2024-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Semaglutide and Preoperative Residual Gastric Volumes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants presenting with a full stomach', 'timeFrame': 'Measured in the preoperative holding area', 'description': 'Full stomach defined as either clear fluid \\> 1.5ml/kg or solid content found with point-of-care gastric antral sonography.'}], 'secondaryOutcomes': [{'measure': 'Number of occurrences requiring change in anesthetic management plan', 'timeFrame': 'From time of preoperative ultrasound in holding area to anesthesia induction in operating room', 'description': 'Changes in plan include those from laryngeal mask airway to more advanced endotracheal tube with rapid sequence induction and intubation or spinal anesthetic without sedation to administration of a general anesthetic.'}, {'measure': 'Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume', 'timeFrame': 'Measured in the preoperative holding area', 'description': 'Explore if dose, duration, and timing of GLP-1 receptor agonist affects gastric volume'}, {'measure': 'Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration', 'timeFrame': 'Measured in the preoperative holding area', 'description': 'Explore if GLP-1 receptor agonist impacts gastric emptying different in patients administering for Type II diabetes mellitus or weight management'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Aspiration']}, 'descriptionModule': {'briefSummary': "Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.\n\nTo address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.\n\nOur primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elective surgical patients meeting inclusion/exclusion criteria at the South Health Campus (Calgary, AB, Canada)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* all elective surgical patients (\\> 18 years of age)\n* followed institutional fasting protocol for surgery\n* patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45)\n* patients not taking GLP-1 receptor agonist (N =45)\n\nExclusion Criteria:\n\n* confounding delayed gastric emptying due to pregnancy\n* previous esophageal or gastric operation\n* etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis)\n* on medication that could potentially cause gastroparesis or delayed gastric or intestinal emptying (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, loperamide, diphenoxylate, oxybutynin, hyoscine butylbromide, scopolamine, promethazine, glycopyrrolate, atropine, chlordiazepoxide, and lithium)"}, 'identificationModule': {'nctId': 'NCT06263595', 'briefTitle': 'Semaglutide and Preoperative Residual Gastric Volumes', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Mitigating Harm: Assessing Preoperative Residual Gastric Volumes to Risk Stratify Patients Administering Semaglutide', 'orgStudyIdInfo': {'id': 'REB23-1754'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GLP-1 Agonist Group', 'description': 'Intervention: elective surgical patients taking GLP-1 receptor agonists', 'interventionNames': ['Device: gastric antral sonography']}, {'label': 'Non GLP-1 Agonist Group', 'description': 'Intervention: elective surgical patients not taking GLP-1 receptor agonists', 'interventionNames': ['Device: gastric antral sonography']}], 'interventions': [{'name': 'gastric antral sonography', 'type': 'DEVICE', 'description': 'Participant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed.', 'armGroupLabels': ['GLP-1 Agonist Group', 'Non GLP-1 Agonist Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3M 1M4', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Joanna J Moser, MD, PhD', 'role': 'CONTACT', 'email': 'joanna.moser@ahs.ca', 'phone': '403-956-3883'}], 'facility': 'South Health Campus', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Joanna J Moser, MD, PhD', 'role': 'CONTACT', 'email': 'joanna.moser@ahs.ca', 'phone': '403-956-3883'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alberta Health services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Joanna Moser', 'investigatorAffiliation': 'University of Calgary'}}}}