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1. Introduction
Scheduled surgery requires patients to undergo a preoperative fasting period of at least 6 hours to reduce the risk of perioperative pulmonary aspiration. However, certain medications and conditions may delay gastric emptying, potentially increasing aspiration risk. These include diabetic gastroparesis and the use of glucagon-like peptide-1 (GLP-1) receptor agonists for the treatment of diabetes and obesity.
GLP-1 receptor agonists are widely used due to their beneficial effects on glycemic control and weight reduction. However, one of their known effects is delayed gastric emptying, which may result in increased residual gastric content despite adherence to standard fasting guidelines. Recent reports have described cases of pulmonary aspiration during anesthesia in patients receiving GLP-1 receptor agonists, even after appropriate fasting.
Given the increasing use of these medications, there is a need for objective assessment tools to evaluate gastric content in the perioperative setting. Gastric ultrasonography has emerged as a non-invasive bedside technique that may help identify patients at increased risk of aspiration and guide airway management strategies.
2. Hypothesis
Gastric ultrasonography performed by trained anesthesiologists is a useful tool for assessing gastric content and may support clinical decision-making in airway management in patients treated with GLP-1 receptor agonists.
3. Methodology
This is a prospective, observational cohort study conducted at participating centers.
The study population consists of adult patients undergoing scheduled surgery under general anesthesia following a standard preoperative fasting period.
Inclusion criteria:
Exclusion criteria:
History of esophagogastric pathology or prior upper abdominal surgery
Hiatal hernia or gastroesophageal reflux disease
Autonomic nervous system disorders
Neurological or neuromuscular diseases
Use of medications affecting gastric emptying (e.g., opioids or prokinetics)
Pregnancy
Presence of clinically significant arrhythmias
4. Description of the Intervention
Immediately prior to anesthesia induction, gastric ultrasonography will be performed by trained investigators at participating centers, with the patient in both supine and right lateral decubitus positions.
Qualitative, semi-quantitative, and quantitative assessments of gastric content and volume will be performed according to the methodology described by Perlas et al. Data will be recorded in a standardized study database.
Anesthetic and surgical management will proceed according to routine clinical practice.
5. Ethical, Legal, and Economic Considerations
Written informed consent will be obtained from all participants prior to study inclusion.
This is an observational study with no modification of standard clinical care. No additional risks beyond routine clinical practice are anticipated.
Gastric ultrasonography will be performed using equipment available at participating centers, and no additional costs are expected.
6. Results
Study data will be analyzed by the investigators. Results will be disseminated through scientific publications and presentations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with GLP-1 agonists | Patients undergoing treatment with GLP-1 agonists, from any geographical area, who choose to undergo scheduled and/or urgent surgery under general anesthesia and/or sedation at our hospital over a two-year period (2024-2025). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Ultrasound | Diagnostic Test | Gastric Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric Ultrasound | Gastric ultrasonography performed by trained anesthesiologists, for measuring gastric content in volume (cm3) is a useful tool for assessing gastric content and making clinical decisions regarding airway management. | Immediately prior to induction of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| weight in kilograms | Weight in kilograms | Immediately prior to induction of anesthesia |
| Height in centimeters | Height in centimeters |
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Inclusion Criteria:
Adults patients ,ASA I-III, taking GLP-1 analog medications, undergoing scheduled surgery.
Exclusion Criteria:
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The reference population will consist of patients undergoing scheduled surgery with a conventional preoperative fasting period (at least 6 hours).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Puga Carrasco, MD | Contact | 0034913531920 | 7633 | cpuga@unav.es |
| Miguel Angel Fernandez-Vaquero, MD,PhD | Contact | 0034913531920 | 7633 | mferva7@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universidad Navarra | Recruiting | Madrid | Madrid | 28027 | Spain |
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| ID | Term |
|---|---|
| D011015 | Pneumonia, Aspiration |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
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| Immediately prior to induction of anesthesia |
| BMI in kg/m^2 | Weight and height will be combined to report BMI in kg/m^2 | Immediately prior to induction of anesthesia |
| CAUSA Salamanca | Recruiting | Salamanca | Spain |
|
| D012140 |
| Respiratory Tract Diseases |