GLP-1 RA Cessation and Gastric Ultrasound Findings
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-65
SponsorWonkwang University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Emergency surgery.
History of prior gastric surgery.
Known gastroparesis or severe gastroesophageal reflux disease.
Declined or unable to provide written informed consent.
Trial population
Adult patients receiving glucagon-like peptide-1 receptor agonists who are scheduled for elective non-cardiac surgery requiring general anesthesia at a tertiary academic hospital. Participants will be screened consecutively by the perioperative anesthesia team and enrolled if eligibility criteria are met.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
GLP-1 RA Cessation Interval
Other interventionObserved 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.
Treatment groups
186 Participants
are divided into 3 treatment groupsGroup A: Last GLP-1 RA Dose 3 Days or Less1 intervention
Group B: Last GLP-1 RA Dose 4 to 7 Days1 intervention
Group C: Last GLP-1 RA Dose 8 Days or More1 intervention
Trial outcomes
Primary outcomes
1
Estimated Gastric Volume Normalized to Body Weight
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.
Time frame
Immediately before induction of anesthesia on the day of surgerySecondary outcomes
1
Antral Cross-Sectional Area
Antral cross-sectional area measured by preoperative point-of-care gastric ultrasound in the right lateral decubitus position and expressed in cm2.
Time frame
Immediately before induction of anesthesia on the day of surgery2
Perlas Gastric Ultrasound Grade
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.
Time frame
Immediately before induction of anesthesia on the day of surgery3
Gastrointestinal Symptom Score
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.
Time frame
Within 24 hours before surgerySponsors and contacts
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Source ClinicalTrials.gov