Semaglutide and Preoperative Residual Gastric Volumes
- Conditions
- Pulmonary Aspiration
- Interventions
- Device: gastric antral sonography
- Registration Number
- NCT06263595
- Lead Sponsor
- University of Calgary
- Brief Summary
Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.
To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.
Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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)
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non GLP-1 Agonist Group gastric antral sonography Intervention: elective surgical patients not taking GLP-1 receptor agonists GLP-1 Agonist Group gastric antral sonography Intervention: elective surgical patients taking GLP-1 receptor agonists
- Primary Outcome Measures
Name Time Method Number of participants presenting with a full stomach Measured in the preoperative holding area Full stomach defined as either clear fluid \> 1.5ml/kg or solid content found with point-of-care gastric antral sonography.
- Secondary Outcome Measures
Name Time Method Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration Measured in the preoperative holding area Explore if GLP-1 receptor agonist impacts gastric emptying different in patients administering for Type II diabetes mellitus or weight management
Number of occurrences requiring change in anesthetic management plan From time of preoperative ultrasound in holding area to anesthesia induction in operating room Changes in plan include those from laryngeal mask airway to more advanced endotracheal tube with rapid sequence induction and intubation or spinal anesthetic without sedation to administration of a general anesthetic.
Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume Measured in the preoperative holding area Explore if dose, duration, and timing of GLP-1 receptor agonist affects gastric volume
Trial Locations
- Locations (1)
South Health Campus
🇨🇦Calgary, Alberta, Canada