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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-100 | Other Identifier | Comité Etico Cientifico Facultad de Medicina Universidad del Desarrollo ClÃnica Alemana |
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This observational study aims to determine the gastric emptying kinetics assessed by ultrasound in healthy volunteers after a standard breakfast and the state of the stomach after a clear liquid diet for 18 /24 hours in patients on GLP-1 agonist. The main questions it seeks to answer are:
Participants will be asked to do:
-A baseline Gastric US will be performed for healthy volunteers, and then they will have a standardized breakfast. An hourly or bihourly assessment will be done by the US.
GLP-1 analogues enhance insulin secretion from β-cells, reduce glucagon secretion, have an appetite-suppressing effect, and delay gastric emptying. This last effect may make standard preoperative fasting inadequate, compromising airway safety during elective surgery and increasing aspiration risk.
The main goal is to gather evidence to determine the optimal fasting period and dietary regimen to ensure safe outpatient surgery without increasing the risk of aspiration.Ultrasound gastric content assessment is a highly accessible, bedside, cost-free, and low-risk tool for anesthesiologists. The increased use of these drugs in surgical patients and the lack of international consensus on their discontinuation and fasting protocols before surgery necessitate further study. Our hypothesis is that GLP-1 analogue users (for weight loss or diabetes) have significantly slower gastric emptying, but a 24-hour liquid regimen may be sufficient to ensure an empty stomach and safe elective surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers after high fat standardized breakfast | GUS will be made |
| |
| Patients on GLP-1 agonist | Patients on GLP-1 agonist after clear fluids diet of 18/24 hrs. GUS will be made. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Ultrasound | Diagnostic Test | A gastric ultrasound will be performed to determine the state of the stomach. Empty, clear fluids, solid, and in case of fluid, the amount of it ( using free tracing) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with each Grade ( stomach content characteristics) according Perlas et al | Grade 0 ( empty in supine and RLD), Grade 1 ( empty supine but liquid content on RDL), Grade 3 ( Solid content or fluid with an area of more than or equal to 10 cm2). | 24 hours tops since the starting of the clear fluid diet |
| Measure | Description | Time Frame |
|---|---|---|
| Area of the stomach in supine and in RLD assessed by ultrasound | Grade 0 ( empty in supine and RLD), Grade 1 ( empty supine but liquid content on RDL), Grade 3 ( Solid content or fluid with an area of more than or equal to 10 cm2). | 24 hours tops since the starting of the clear fluid diet |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteers will be assessed for emptying the stomach after a standardized high-fat meal, by ultrasound.
Cohort of patients on a GLP-1 agonist after 18/24 hours of clear fluids.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javiera Vargas, MD, MSc | Contact | +56957383772 | jpvargasz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cristian Arzola, MD, MSc | Universidad de Toronto | Study Chair |
| Juan Pablo Ghiringelli | Universidad de Valparaiso | Study Director |
| Miguel vega, MD |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Universidad del Desarrollo |
| Study Director |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |