Using gastric ultrasound to check stomach contents in patients on semaglutide
Gastric Ultrasound To Assess Gastric Contents In Patients On Semaglutide Therapy
This study is testing how semaglutide affects stomach contents in patients preparing for surgery to help doctors manage anesthesia better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06292065 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of semaglutide therapy on gastric contents in patients undergoing elective surgery. It utilizes point-of-care gastric ultrasound to assess gastric emptying and contents in patients who are on semaglutide, a medication commonly used for type 2 diabetes and weight loss. The study aims to clarify the impact of semaglutide on gastric volume, which is crucial for anesthetic management. Participants will include those on semaglutide therapy and a control group of patients not on the medication, both preparing for general anesthesia.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are on semaglutide therapy and scheduled for elective surgery requiring general anesthesia.
Not a fit: Patients not undergoing elective surgery or those not on semaglutide therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve preoperative safety by providing better guidelines for managing patients on semaglutide during anesthesia.
How similar studies have performed: While there is limited data on the specific use of gastric ultrasound in this context, similar studies have explored the effects of GLP-1 receptor agonists on gastric emptying with varying results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for the semaglutide cohort are: * Adults (\>=18 years old) * Semaglutide therapy for any indication (type 2 diabetes or weight loss) * Semaglutide therapy at any dose * Semaglutide therapy with any route of administration * Semaglutide therapy administered daily or weekly * Semaglutide therapy at any time since initiation * Elective surgery of any kind for which general anaesthesia was planned preoperatively * Adherence to current ASA recommendation regarding GLP-1-RA; i.e. holding semaglutide for 1 week if administered weekly or for 1 day if administered daily. * Adherence to current ESAIC fasting guidelines; i.e. \>2 hours for liquids and \>6 hours for solid foods. Inclusion criteria for the control cohort are: * Adults (\>=18 years old) * Elective surgery of any kind for which general anaesthesia was planned preoperatively * Adherence to current ESAIC fasting guidelines; i.e. \>2 hours for liquids and \>6 hours for solid foods Exclusion criteria for the semaglutide cohort are: * Semaglutide not held in accordance with current ASA recommendation, i.e. held either longer or shorter than recommended. * No adherence to current ESAIC fasting guideline * Presence of a contra-indication to gastric ultrasound; i.e. previous gastric surgery (e.g. partial gastrectomy, gastric bypass) or hiatal hernias. * Presence of comorbidities associated with delayed gastric emptying: scleroderma, systemic lupus erythematosus, hypothyroidism, Parkinson disease, cerebral palsy, and multiple sclerosis. * Inability to assume the right lateral decubitus position * Initial anaesthetic plan did not involve general anaesthesia, e.g. neuraxial or locoregional cases Exclusion criteria for the control cohort are: * Semaglutide or other GLP-1-RA therapy * No adherence to current ESAIC fasting guideline * Presence of a contra-indication to gastric ultrasound; i.e. previous gastric surgery (e.g. partial gastrectomy, gastric bypass) or hiatal hernias * Presence of comorbidities associated with delayed gastric emptying: scleroderma, systemic lupus erythematosus, hypothyroidism, Parkinson disease, cerebral palsy, and multiple sclerosis * Inability to assume the right lateral decubitus position * Initial anaesthetic plan does not involve general anaesthesia, e.g. locoregional cases
Where this trial is running
Edegem, Antwerp
- Antwerp University Hospital — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Nils Vlaeminck, MD — University Hospital, Antwerp
- Study coordinator: Nils Vlaeminck, MD
- Email: nils.vlaeminck@uza.be
- Phone: 038213044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.