Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Location status: Recruiting
Location contact
Christopher Wolla, M.D.
PRINCIPAL_INVESTIGATOR
Haley Nitchie, MHA
CONTACT
NCT Number: NCT07251803
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Charleston, South Carolina, 29425, United States
Location status: Recruiting
Christopher Wolla, M.D.
PRINCIPAL_INVESTIGATOR
Haley Nitchie, MHA
CONTACT
Patients will be classified into one of two groups:
or
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.
If based on the formula: GV (mL) = 27.0+(14.6*CSA)-(1.28*age) the patient is shown to have a gastric volume greater than 1.5mL/kg, or Antral Grade 2, the anesthesiologist assigned to the case will be alerted and will determine whether or not it is safe to continue with the scheduled surgery as the risk for aspiration may be higher based on the gastric ultrasound results.
Qualitative grading of the appearance of the gastric antrum in RLD will be graded as follows:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All participants will undergo a gastric ultrasound in the preoperative area prior to their scheduled procedure. 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.
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).
Time frame: From enrollment until completion of gastric ultrasound (within 3 hours of scheduled procedure).
Qualitative grading of the appearance of the gastric antrum in right lateral decubitus (RLD) will be graded as follows:1
Time frame: From time of enrollment until the start of surgery, up to 24 hours.
Incidence of full stomach defined as solid or thick liquids on US or >1.5mL/kg of clear liquid upon gastric ultrasound.
Time frame: From induction of anesthesia until end of surgery (up to 8 hours).
Time frame: Assessed at enrollment and during gastric ultrasound (within 3 hours of scheduled procedure).
Time frame: assessed at time of enrollment from the past 30 days until completion of gastric ultrasound
High Risk includes:
Low dose and high dose are classified as:
Oral Semaglutide (Rybelsus) Low dose: < 5 mg High dose: > 5 mg
Tirzepatide (Mounjaro and Zepbound) Low dose: 2.5, 5, and 7.5 mg High dose: 10, 12.5, 15 mg
SubQ Semaglutide (Ozempic and Wegovy) Low dose: 0.25 and 0.5 mg High dose: 1 and 2 mg
Dulaglutide (Trulicity) Low dose: 0.75 and 1.5 mg High dose: 3.0 and 4.5 mg
Liraglutide (Victoza) Low dose: 0.6 mg High dose: 1.2 and 1.8 mg
Exenatide (Byetta) Low dose: 5 mcg High dose: 10 mcg
Contact information is provided by the study sponsor or research team.
Medical University of South Carolina
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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