An Observational Study to Examine Non-inferiority of the Standard ASA Fasting Guidelines Versus 24-hour Clear Liquid Diet for Gastric Volume in Patients Taking GLP-1 Agonists
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Pre-operative gastric volume per unit of weight (ml/kg) as assessed by gastric ultrasound.
Study Overview
Brief Summary
This study will enroll patients 18 years and older who are taking a GLP-1/GIP medication and 1) are scheduled for elective surgery and meet ASA fasting guidelines (nothing by mouth for at least 8 hours prior), or 2) scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior. Participants will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The purpose of this study is to determine if people taking GLP-1 receptor agonists and who fast normally are at an equal risk for having retained gastric contents after appropriately fasting for surgery, compared to patients who are on a liquid only diet for 24 hours prior to surgery.
Detailed Description
Patients will be classified into one of two groups:
- Taking a GLP-1/GLP-GIP medication and undergoing an elective colonoscopy and have been on a clear liquid diet for the past 24-hours.
or 2. Taking a GLP-1/GLP-GIP medication and undergoing am elective surgery and have fasted appropriately according to ASA guidelines.
All participants will undergo a gastric ultrasound in the preoperative area prior to their scheduled procedure. This will be completed to determine the amount of retained gastric contents, if any, after fasting properly prior to the procedure. An anesthesiologist attending who is properly trained on performing gastric ultrasounds and listed as a study team member will be the one performing the scan.
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 (RLD), and the above procedure will be repeated. The measurement of gastric antral cross-sectional area while in the RLD position will be recorded and used to calculate the gastric volume.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have taken a GLP-1 or GLP-GIP agonist medication within the past 30 days
- •ASA Physical Classification Status 1-3
- •Fall into one of the following groups:
- •Scheduled elective surgery and meet ASA fasting guidelines (NPO for at least 8 hours prior)
- •Scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior
Exclusion Criteria
- •Previous gastric or esophageal surgery
- •Abnormal gastric anatomy
- •Pregnancy
- •Unable to provide written, informed consent
- •Non-English speaking
Arms & Interventions
ASA fasting guidelines
Scheduled elective surgery and meet ASA fasting guidelines (NPO for at least 8 hours prior)
Intervention: Gastric Ultrasound (Diagnostic Test)
24-hour clear liquid diet
Scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior
Intervention: Gastric Ultrasound (Diagnostic Test)
Outcomes
Primary Outcomes
Pre-operative gastric volume per unit of weight (ml/kg) as assessed by gastric ultrasound.
Time Frame: From enrollment until completion of pre-operative gastric ultrasound (typically within 3 hours of scheduled procedure).
While the patient is in supine position, the gastric volume will be measured via ultrasound and then calculated using a validated formula, GV (mL) = 27.0+(14.6\*CSA)-(1.28\*age).
Secondary Outcomes
- Perlas antral grade(From enrollment until completion of gastric ultrasound (within 3 hours of scheduled procedure).)
- Incidence of full stomach on gastric ultrasound assessment(From time of enrollment until the start of surgery, up to 24 hours.)
- Incidence of regurgitation under anesthesia(From induction of anesthesia until end of surgery (up to 8 hours).)
- Incidence of change in anesthetic management based on stomach contents(Assessed at enrollment and during gastric ultrasound (within 3 hours of scheduled procedure).)
- Differences in "high risk GLP-1" vs "low risk GLP-1"(assessed at time of enrollment from the past 30 days until completion of gastric ultrasound)
Investigators
Christopher Wolla
Assistant Professor-Faculty
Medical University of South Carolina