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Completed

NCT Number: NCT06263595

Semaglutide and Preoperative Residual Gastric Volumes

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.

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Key information

Conditions

Pulmonary Aspiration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

gastric antral sonography

Device

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.

Primary outcomes

  1. Number of participants presenting with a full stomach

    Time frame: 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 outcomes

  1. Number of occurrences requiring change in anesthetic management plan

    Time frame: 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.

  2. Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume

    Time frame: Measured in the preoperative holding area

    Explore if dose, duration, and timing of GLP-1 receptor agonist affects gastric volume

  3. Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 16, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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