Gastric Ultrasound To Assess Gastric Contents In Patients On Semaglutide Therapy

NCT06292065 | Completed

• 1 other identifier: Project ID 6171
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1-RA) such as semaglutide (Ozempic™, Rybelsus™, Wegovy™) were first introduced as a therapeutic agent for type 2 diabetes mellitus but they are being increasingly used to target weight loss in obesity. One of the mechanisms by which weight loss is achieved, is increased satiety and significantly delayed gastric emptying. Tachyphylaxis for this effect has been reported with chronic use of long acting GLP-1-RA (e.g. semaglutide) but this was based on the paracetamol absorption technique or 13C breath test. Recent clinical data suggests semaglutide use does increase perioperative gastric content.This creates uncertainty for anaesthetists who are, anecdotally, more frequently faced with patients who may or may not have full stomachs despite adhering to conventional fasting guidelines. To address this issue the American Society of Anesthesiologists (ASA) has recently released guidelines in which it advises to hold GLP-1-RA for one day (if administered daily) or one week (if administered weekly). However, these recommendations are based on sparse empirical evidence and they do not necessarily follow from the known pharmacokinetic properties of these drugs. Typically, GLP-1-RA are administered in increasing doses over several weeks until a therapeutic steady state is achieved. Meanwhile the elimination half-life of e.g. semaglutide is 7 days. This means that holding semaglutide for one day or even one week might not be enough to attenuate its therapeutic effect of delayed gastric emptying. On the other hand if semaglutide were to be held for e.g. 5 terminal half-lifes, this would mean an unpractical 5 weeks during which glycemic control may be worsened and after which semaglutide doses would have to be incrementally increased again. Besides, hyperglycaemia secondary to semaglutide cessation can also delay gastric emptying. Further confounding the assessment of these patients there can be 'background' delayed gastric emptying in diabetic patients and more pronounced delayed gastric emptying in patients recently started on GLP-1-RA. The presence of gastro-intestinal symptoms (nausea, vomiting, dyspepsia, abdominal distension) might offer clinical information regarding increased gastric residue in this population. Gastric ultrasound is a point-of-care clinical and research tool that has steadily gained popularity to assess gastric content in patients not compliant with fasting rules or with certain comorbidities. Clinical decisions can be made based on the visualised content (e.g. solids, fluids or nothing) or through calculation of gastric volume by measuring antral circumference. In this study the investigators will examine gastric contents in patients who are taking semaglutide and in patients who are not. The investigators will then evaluate whether there is a difference in the incidence of full stomachs and whether gastric ultrasound influenced the anaesthetic plan of the treating anaesthetist.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Prevalence of full stomach

  The prevalence of a full stomach based on gastric ultrasound (solids visible in any visualisation or calculated liquid gastric content exceeding 1.5 ml/kg of total body weight) in patients taking semaglutide compared to controls

  Immediately preoperatively

Secondary Outcomes (27)

• Frequency of changes to the anaesthetic plan

  Immediately preoperatively

• Calculated gastric content

  Immediately preoperatively

• Prevalence of solid gastric content

  Immediately preoperatively

• Association between fasting time for solids and 'full stomach'

  Immediately preoperatively

• Association between fasting time for liquids and 'full stomach'

  Immediately preoperatively

Study Arms (1)

Gastric Ultrasound

EXPERIMENTAL

Gastric ultrasound will be performed shortly before induction; i.e. in the preoperative room. The exam will be performed by the treating anaesthetist experienced with gastric ultrasound. The gastric antrum will be visualised in supine position followed by a second visualisation of the antrum in right lateral decubitus. In the latter position the cross-sectional area of the antrum (RIGHT-LAT CSA) will be measured and used to calculate the gastric volume using the \[VOLUME (ML) = 27.0 + 14.6 X RIGHT-LAT CSA - 1.28 X AGE\] formula. The patient will be considered to have a full stomach or positive gastric ultrasound if solid gastric content is visible in any visualisation of the antrum or if calculated liquid gastric content exceeds 1.5 ml/kg of total body weight.

Diagnostic Test: Point-of-care gastric ultrasound

Interventions

Point-of-care gastric ultrasound DIAGNOSTIC_TEST

Using ultrasound to visualise the gastric antrum in supine position and right lateral decubitus.

Gastric Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>=18 years old)
• Semaglutide therapy for any indication (type 2 diabetes or weight loss)
• Semaglutide therapy at any dose
• Semaglutide therapy with any route of administration
• Semaglutide therapy administered daily or weekly
• Semaglutide therapy at any time since initiation
• Elective surgery of any kind for which general anaesthesia was planned preoperatively
• Adherence to current ASA recommendation regarding GLP-1-RA; i.e. holding semaglutide for 1 week if administered weekly or for 1 day if administered daily.
• Adherence to current ESAIC fasting guidelines; i.e. \>2 hours for liquids and \>6 hours for solid foods.
• Adults (\>=18 years old)
• Elective surgery of any kind for which general anaesthesia was planned preoperatively
• Adherence to current ESAIC fasting guidelines; i.e. \>2 hours for liquids and \>6 hours for solid foods

You may not qualify if:

• Semaglutide not held in accordance with current ASA recommendation, i.e. held either longer or shorter than recommended.
• No adherence to current ESAIC fasting guideline
• Presence of a contra-indication to gastric ultrasound; i.e. previous gastric surgery (e.g. partial gastrectomy, gastric bypass) or hiatal hernias.
• Presence of comorbidities associated with delayed gastric emptying: scleroderma, systemic lupus erythematosus, hypothyroidism, Parkinson disease, cerebral palsy, and multiple sclerosis.
• Inability to assume the right lateral decubitus position
• Initial anaesthetic plan did not involve general anaesthesia, e.g. neuraxial or locoregional cases
• Semaglutide or other GLP-1-RA therapy
• No adherence to current ESAIC fasting guideline
• Presence of a contra-indication to gastric ultrasound; i.e. previous gastric surgery (e.g. partial gastrectomy, gastric bypass) or hiatal hernias
• Presence of comorbidities associated with delayed gastric emptying: scleroderma, systemic lupus erythematosus, hypothyroidism, Parkinson disease, cerebral palsy, and multiple sclerosis
• Inability to assume the right lateral decubitus position
• Initial anaesthetic plan does not involve general anaesthesia, e.g. locoregional cases

Sponsors & Collaborators

• Nils Vlaeminck: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nils Vlaeminck, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: 45 patients on semaglutide therapy will be included together with 45 age, BMI and diabetes status matched controls.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 4, 2024
• Study Start: April 16, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)