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University of CalgarySemaglutide and Preoperative Residual Gastric Volumes 90
Clinical Trial NCT06263595 is an observational study for Pulmonary Aspiration that is recruiting. It started on 31 May 2024 with plans to enroll 90 participants. Led by University of Calgary, it is expected to complete by 31 July 2025. The latest data from ClinicalTrials.gov was last updated on 25 March 2025.
Brief Summary
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 rece...Show More
Official Title
Mitigating Harm: Assessing Preoperative Residual Gastric Volumes to Risk Stratify Patients Administering Semaglutide
Conditions
Pulmonary AspirationOther Study IDs
- REB23-1754
NCT ID Number
Start Date (Actual)
2024-05-31
Last Update Posted
2025-03-25
Completion Date (Estimated)
2025-07-31
Enrollment (Estimated)
90
Study Type
Observational
Status
Recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
GLP-1 Agonist Group Intervention: elective surgical patients taking GLP-1 receptor agonists | gastric antral sonography 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. |
Non GLP-1 Agonist Group Intervention: elective surgical patients not taking GLP-1 receptor agonists | gastric antral sonography 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of participants presenting with a full stomach | Full stomach defined as either clear fluid \> 1.5ml/kg or solid content found with point-of-care gastric antral sonography. | Measured in the preoperative holding area |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of occurrences requiring change in anesthetic management plan | 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. | From time of preoperative ultrasound in holding area to anesthesia induction in operating room |
Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume | Explore if dose, duration, and timing of GLP-1 receptor agonist affects gastric volume | Measured in the preoperative holding area |
Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration | Explore if GLP-1 receptor agonist impacts gastric emptying different in patients administering for Type II diabetes mellitus or weight management | Measured in the preoperative holding area |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- all elective surgical patients (> 18 years of age)
- followed institutional fasting protocol for surgery
- patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45)
- patients not taking GLP-1 receptor agonist (N =45)
- confounding delayed gastric emptying due to pregnancy
- previous esophageal or gastric operation
- etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis)
- 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)
University of Calgary215 active studies to exploreAlberta Health servicesStudy Responsible Party
Joanna Moser, Principal Investigator, Clinical Assistant Professor, University of Calgary
Study Central Contact
Contact: Joanna J Moser, MD, PhD, 403-956-3883, [email protected]
1 Study Locations in 1 Countries
Alberta
South Health Campus, Calgary, Alberta, T3M 1M4, Canada
Joanna J Moser, MD, PhD, Contact, 403-956-3883, [email protected]
Recruiting