Assessing gastric volumes in patients taking GLP-1 agonists before surgery
Mitigating Harm: Assessing Preoperative Residual Gastric Volumes to Risk Stratify Patients Administering Semaglutide
University of Calgary · NCT06263595
This study is testing how much food is left in the stomach of patients taking GLP-1 medications before surgery to see if they need special care to avoid complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary (other) |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT06263595 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate preoperative residual gastric volumes in patients taking GLP-1 receptor agonists using point-of-care ultrasound (POCUS). The research addresses the increased risk of pulmonary aspiration in these patients, as current fasting guidelines may not be adequate. By measuring gastric volumes, the study seeks to identify patient populations that require risk stratification and to develop specific guidelines to minimize anesthetic complications. The study includes both patients on GLP-1 agonists and those not on these medications for comparison.
Who should consider this trial
Good fit: Ideal candidates include elective surgical patients over 18 years of age who are following institutional fasting protocols and are either taking or not taking GLP-1 receptor agonists.
Not a fit: Patients with conditions that cause delayed gastric emptying or those who have had previous gastric surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety protocols for patients on GLP-1 agonists undergoing surgery, reducing the risk of aspiration pneumonia.
How similar studies have performed: While this approach is novel in the context of GLP-1 agonists, similar studies have shown the importance of assessing gastric volumes to prevent aspiration risks in surgical patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * all elective surgical patients (\> 18 years of age) * followed institutional fasting protocol for surgery * patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45) * patients not taking GLP-1 receptor agonist (N =45) Exclusion Criteria: * confounding delayed gastric emptying due to pregnancy * previous esophageal or gastric operation * etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis) * on medication that could potentially cause gastroparesis or delayed gastric or intestinal emptying (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, loperamide, diphenoxylate, oxybutynin, hyoscine butylbromide, scopolamine, promethazine, glycopyrrolate, atropine, chlordiazepoxide, and lithium)
Where this trial is running
Calgary, Alberta
- South Health Campus — Calgary, Alberta, Canada (RECRUITING)
Study contacts
- Study coordinator: Joanna J Moser, MD, PhD
- Email: joanna.moser@ahs.ca
- Phone: 403-956-3883
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.
Conditions: Pulmonary Aspiration