Detroit Medical Center
Detroit, Michigan, 482001, United States
NCT Number: NCT07140289
This study aims to assess the effect of using Glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists on gastric emptying on surgical patients and whether specific guidelines need to be established for these patients. GLP-1 receptor agonists are mainly used for the treatment and mitigation of obesity and metabolic syndromes. One of their mechanisms of action is by delaying gastric emptying, hence increasing satiety. However, patients need to abstain from eating for a set amount of time before surgery to reduce the risk of aspiration. Hence patients who use GLP-1 receptor agonists may need more time to abstain eating (nil-per-os). In this study we aim to assess how much time is sufficient before surgery in these specific population of patients.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Detroit, Michigan, 482001, United States
Diabetes is a global health issue. It is the leading cause of death and disability worldwide. More than 1.31 billion people are projected to have diabetes in the world by 2050. Similarly in the United States total prevalence of diabetes is projected to be around 21% of the US population by 2050. Glucagon-like peptide-1 receptor agonists (GLP-1 RA), alternatively referred to as incretin mimetics, or GLP-1 analogs, constitute a category of drugs utilized for the management of type 2 diabetes mellitus and also for obesity. Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are hormones known as incretin hormones. GIP hormones play a role in stimulating the release of insulin after consuming glucose, which is referred to as the incretin effect. However, in people with type 2 diabetes, this process can be diminished or absent. Pharmacological levels of GLP-1 can help restore insulin secretion in individuals with type 2 diabetes. The advantages of using this approach for treating type 2 diabetes include the slowing down of stomach emptying and the suppression of glucagon production from pancreatic alpha cells when blood sugar levels are high. Additionally, GLP-1 RAs have the potential to reduce the death of pancreatic beta cells (the cells responsible for producing insulin) while also encouraging their growth.
Recent literature have raised concerns about the potential of GLP-1 RA-induced delayed gastric emptying to heighten the risk of regurgitation and inhalation of stomach contents during instances of general anesthesia and profound sedation. The term "high-risk stomach" refers to gastric volume carrying a heightened pulmonary aspiration risk, typically defined as liquid content exceeding 1.5 ml/kg or the presence of solid matter, as commonly described in literature. Gastric ultrasound has been used as an important tool for assessing the gastric content and volume. Measurement of the antral cross-sectional area by ultrasound with subsequent calculation of gastric volume can determine the low risk or high-risk stomach accordingly (8.
In June 2023, the ASA (American Society of Anesthesiologists) released a consensus-based guideline regarding the preoperative management of patients using GLP-1 RA. The recommendation advised taking these medications either on the day before or on the day of the procedure. Patients on a weekly regimen were advised to suspend the drug for the entire week. Although there are general fasting recommendations for the general population, no fasting recommendations were provided for patients on GLP-1 RA due to insufficient supporting evidence.
This research aims to increase our understanding about the effect of use of GLP-1 RAs on gastrointestinal motility and gastric emptying. The results of this study may provide insight regarding acceptable timing of NPO (Non per oral) before surgical procedures to reduce the risk of aspiration and other related complications.
The following information will be obtained from the patients in their visit:
Gastric Ultrasound Finding reporting items:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An ultrasound examination of the abdomen to observe and measure gastric contents
Time frame: Preoperatively on the day of surgery (between admission to preoperative testing and start of surgical procedure).
Ultrasound measurement of the right- lateral cross-sectional area measurement of the gastric antrum measured pre-operatively
Time frame: Between induction of anesthesia and discharge (up to 4 hours) from the post-anesthesia care unit after surgery
Documented clinical evidence of aspiration (e.g., witnessed event, presence of aspirated material in airway, or new infiltrate on chest imaging consistent with aspiration)
Time frame: Within 7 days of surgery (if data is available)
Diagnosis based on clinical criteria (fever, leukocytosis, new infiltrate on chest X-ray, hypoxemia) and/or microbiological confirmation
Time frame: Within 7 days of surgery (if data is available)
New or worsening respiratory disease (e.g., ARDS, acute respiratory failure, need for escalation of ventilatory support)
Time frame: Within 7 days of surgery (if data is available)
Requirement for repeat endotracheal intubation due to respiratory compromise attributed to aspiration
Time frame: Up to hospital discharge (up to 30 Days)
Number of days in ICU following aspiration event (up to 30 days)
Time frame: Up to 30 days
Number of days in hospital following aspiration event
Time frame: Within 30 days of surgery (if data is available)
All-cause mortality within 30 days of aspiration event
Time frame: Within 7 days of surgery (if data is available)
New onset infection (e.g., sepsis), fever, or other systemic complications following aspiration
Time frame: Between emergence from anesthesia and discharge from the post-anesthesia care unit after surgery
Oxygen saturation <90% requiring intervention (supplemental O₂, airway support)
Time frame: Within 7 days of surgery (if data is available)
Requirement for repeat endotracheal intubation or advanced airway management due to respiratory compromise attributed to aspiration
Time frame: Between emergence from anesthesia and discharge from the post-anesthesia care unit after surgery
Composite of events including laryngospasm, bronchospasm, upper airway obstruction, or need for noninvasive ventilation
Wael Saasouh, MD
Other
The Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying Before Elective Surgery
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