Delayed Gastric Emptying, Residual Gastric Contents
Conditions
Brief summary
This prospective observational study will evaluate the association between the time interval since the last dose of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and residual gastric contents before elective surgery. Adult patients receiving GLP-1 RAs and scheduled for elective non-cardiac surgery under general anesthesia will undergo preoperative point-of-care gastric ultrasound. The study will assess whether longer GLP-1 RA cessation intervals are associated with lower ultrasound-estimated gastric volume and a lower frequency of high-risk gastric contents. Body mass index will also be evaluated as a potential modifier of this association.
Detailed description
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly used for the treatment of type 2 diabetes and obesity. These agents can delay gastric emptying, raising concerns about residual gastric contents and potential aspiration risk during anesthesia. Current perioperative recommendations regarding GLP-1 RA discontinuation are largely consensus-based, and the physiological relationship between cessation interval and residual gastric content remains insufficiently defined. This single-center prospective observational cohort study will enroll adult patients who are receiving GLP-1 RAs and are scheduled for elective non-cardiac surgery requiring general anesthesia. GLP-1 RA management will follow usual clinical care; the study team will not assign, modify, or instruct the timing of drug discontinuation. The primary exposure will be the number of days since the last GLP-1 RA dose, analyzed both as a continuous variable and according to prespecified cessation-interval categories. Immediately before induction of anesthesia, participants will undergo standardized point-of-care gastric ultrasound. Qualitative gastric content will be assessed using the Perlas grading system, and quantitative gastric volume will be estimated from the antral cross-sectional area measured in the right lateral decubitus position. The primary outcome will be estimated gastric volume normalized to body weight. Secondary outcomes will include antral cross-sectional area, Perlas grade, and the presence of high-risk gastric contents. Multivariable regression models will be used to evaluate the association between GLP-1 RA cessation interval and gastric ultrasound findings after adjustment for clinically relevant covariates, including age, sex, body mass index, diabetes status, preoperative fasting duration, and gastrointestinal symptom score. Body mass index will be evaluated as a prespecified effect modifier.
Interventions
OTHERGLP-1 RA Cessation Interval
Observed exposure defined as the number of days between the participant's last glucagon-like peptide-1 receptor agonist dose and elective surgery. Participants were categorized according to time since last dose: 3 days or less, 4 to 7 days, and 8 days or more. No GLP-1 receptor agonist was assigned, administered, continued, or discontinued by the study protocol; medication management followed usual clinical care.
Sponsors
Wonkwang University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Inclusion criteria
* Adults aged 18 years or older. * Patients receiving a glucagon-like peptide-1 receptor agonist. * Patients scheduled for elective non-cardiac surgery requiring general anesthesia. * Patients able to provide written informed consent.
Exclusion criteria
* Emergency surgery. * History of prior gastric surgery. * Known gastroparesis or severe gastroesophageal reflux disease. * Declined or unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Gastric Volume Normalized to Body Weight | Immediately before induction of anesthesia on the day of surgery | Estimated gastric volume normalized to body weight, expressed as mL/kg, calculated from the antral cross-sectional area measured by preoperative point-of-care gastric ultrasound in the right lateral decubitus position. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antral Cross-Sectional Area | Immediately before induction of anesthesia on the day of surgery | Antral cross-sectional area measured by preoperative point-of-care gastric ultrasound in the right lateral decubitus position and expressed in cm2. |
| Perlas Gastric Ultrasound Grade | Immediately before induction of anesthesia on the day of surgery | Qualitative gastric content will be assessed using the Perlas Gastric Ultrasound Grading System, which ranges from Grade 0 to Grade 2. Grade 0 indicates an empty stomach, Grade 1 indicates fluid visible only in the right lateral decubitus position, and Grade 2 indicates fluid visible in both the supine and right lateral decubitus positions. Higher grades indicate greater residual gastric content. |
| Gastrointestinal Symptom Score | Within 24 hours before surgery | Preoperative gastrointestinal symptoms will be assessed using a Gastrointestinal Symptom Numeric Rating Scale for nausea, vomiting, bloating, early satiety, and abdominal discomfort. Each symptom is rated from 0 to 10, where 0 indicates no symptom and 10 indicates the worst imaginable symptom. The total score ranges from 0 to 50, with higher scores indicating more severe gastrointestinal symptoms. |
Countries
South Korea
Contacts
STUDY_DIRECTORCheol Lee, M.D.,Ph.D
Wonkwang University Hosptial
Outcome results
None listed