Diabetes, Gastric Content Aspiration, GLP-1, Glucagon-like Peptide 1
Conditions
Brief summary
This study will enroll patients ages 18 and over who have a diagnosis of diabetes, are undergoing an elective surgery under general anesthesia and 1) are taking a GLP-1 receptor agonist medication, or 2) not taking a GLP-1 receptor agonist medication. The patients will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The primary goal is to assess the effect of subcutaneous injectable GLP-1 agonists on preoperative gastric volume in fasted, diabetic surgical patients.
Interventions
DIAGNOSTIC_TESTGastric Ultrasound
A gastric ultrasound will be completed on every patient and administered the same way in each arm. The patient will be placed in supine position. A curvilinear ultrasound probe will be placed on the sagittal plane below the xiphoid process. The probe will then slide along the costal margin to the right until the gastric antrum is identified. At this point, the ultrasound image will be obtained, and appropriate measurements will be taken. The patient will be placed in the right lateral decubitus position and the above procedure will be repeated.
Sponsors
Medical University of South Carolina
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years old * Diagnosed with diabetes (listed on medical record, Hgb A1C greater than or equal to 6.5%, fasting blood glucose greater than or equal to 126mg/dL, and/or on medical treatment for diabetes) * One of the following groups: * Taking a GLP-1 Medication * Not taking a GLP-1 Medication * ASA Physical Classification Status 1-3 * Scheduled for elective surgery under general anesthesia * Appropriately fasted per ASA Fasting Guidelines 201712
Exclusion criteria
* BMI greater than 40 * Previous gastric/esophageal surgery * Abnormal gastric anatomy * Pregnancy * Inability or unwillingness of subject to give informed consent * Non-English Speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric Volume in RLD Position | From time of enrollment until the start of surgery, assessed up to 4 weeks | The gastric volume will be calculated using a validated formula. |
Secondary
| Measure | Time frame |
|---|---|
| Gastric antrum CSA in RLD position | From time of enrollment until the start of surgery, assessed up to 4 weeks |
| Perlas antral grade | From time of enrollment until the start of surgery, assessed up to 4 weeks |
| Incidence of aspiration | From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours |
Countries
United States
Outcome results
None listed