Semaglutide and Preoperative Residual Gastric Volumes

Pulmonary Aspiration Clinical Trial

Official title:

Mitigating Harm: Assessing Preoperative Residual Gastric Volumes to Risk Stratify Patients Administering Semaglutide

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06263595
• Other study ID #: REB23-1754
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Calgary
• Contact: Joanna J Moser, MD, PhD
• Phone: 403-956-3883
• Email: joanna.moser[@]ahs.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pulmonary Aspiration

Intervention

Device:
• gastric antral sonography
Participant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed.

Locations

Country	Name	City	State
Canada	South Health Campus	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants presenting with a full stomach	Full stomach defined as either clear fluid > 1.5ml/kg or solid content found with point-of-care gastric antral sonography.	Measured in the preoperative holding area
Secondary	Number of occurrences requiring change in anesthetic management plan	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.	From time of preoperative ultrasound in holding area to anesthesia induction in operating room
Secondary	Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume	Explore if dose, duration, and timing of GLP-1 receptor agonist affects gastric volume	Measured in the preoperative holding area
Secondary	Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration	Explore if GLP-1 receptor agonist impacts gastric emptying different in patients administering for Type II diabetes mellitus or weight management	Measured in the preoperative holding area