Clinical trial NCT06263595: Semaglutide and Preoperative Residual Gastric Volumes
Official title: Mitigating Harm: Assessing Preoperative Residual Gastric Volumes to Risk Stratify Patients Administering Semaglutide
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Aspiration
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2024-02-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective surgical patients meeting inclusion/exclusion criteria at the South Health Campus (Calgary, AB, Canada)

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.


Eligibility 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)

Primary outcomes:
measure: Number of participants presenting with a full stomach
timeFrame: Measured in the preoperative holding area
Secondary outcomes:
measure: Number of occurrences requiring change in anesthetic management plan
timeFrame: From time of preoperative ultrasound in holding area to anesthesia induction in operating room
measure: Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume
timeFrame: Measured in the preoperative holding area
measure: Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration
timeFrame: Measured in the preoperative holding area
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
Study officials:
References: