Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06292065
Other study ID # Project ID 6171
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 16, 2024
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source University Hospital, Antwerp
Contact Nils Vlaeminck, MD
Phone 038213044
Email nils.vlaeminck@uza.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status 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 for the semaglutide cohort are: - 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. Inclusion criteria for the control cohort are: - 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 Exclusion criteria for the semaglutide cohort are: - 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 Exclusion criteria for the control cohort are: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Point-of-care gastric ultrasound
Using ultrasound to visualise the gastric antrum in supine position and right lateral decubitus.

Locations

Country Name City State
Belgium Antwerp University Hospital Edegem Antwerp

Sponsors (1)

Lead Sponsor Collaborator
Nils Vlaeminck

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Frequency of changes to the anaesthetic plan The frequency of changes to the anaesthetic plan (including postponement of surgery, change to locoregional or neuraxial technique, rapid sequence intubation, choice of airway, preoperative placement of nasogastric suctioning) after gastric ultrasound in semaglutide patients compared to controls Immediately preoperatively
Secondary Calculated gastric content The calculated gastric content (median) based on gastric ultrasound in semaglutide patients compared to controls. Immediately preoperatively
Secondary Prevalence of solid gastric content The prevalence of solid gastric content visible on gastric ultrasound in semaglutide patients compared to controls Immediately preoperatively
Secondary Association between fasting time for solids and 'full stomach' The correlation between fasting time for solids and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Association between fasting time for liquids and 'full stomach' The correlation between fasting time for liquids and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Frequency of perioperative aspiration The frequency of perioperative aspiration of gastric contents in semaglutide patients compared to controls Immediately postoperatively
Secondary Prevalence of gastric symptoms The prevalence of gastric symptoms (nausea, vomiting, dyspepsia, abdominal distension) in semaglutide patients compared to controls Immediately preoperatively
Secondary Association between nausea and 'full stomach' The correlation between nausea and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Association between vomiting and 'full stomach' The correlation between vomiting and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Association between dyspepsia and 'full stomach' The correlation between dyspepsia and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Association between abdominal distension and 'full stomach' The correlation between abdominal distension and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary association between semaglutide dose and calculated gastric content The correlation between semaglutide dose and calculated gastric content on gastric ultrasound Immediately preoperatively
Secondary association between semaglutide dose and 'full stomach' The correlation between semaglutide dose and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Association between frequency of semaglutide administration and calculated gastric content The correlation between frequency of semaglutide administration and calculated gastric content on gastric ultrasound Immediately preoperatively
Secondary Association between frequency of semaglutide administration and 'full stomach' The correlation between frequency of semaglutide administration and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Association between duration of semaglutide therapy and calculated gastric content The correlation between duration of semaglutide therapy and calculated gastric content on gastric ultrasound Immediately preoperatively
Secondary Association between duration of semaglutide therapy at current dose and calculated gastric content The correlation between duration of semaglutide therapy at current dose and calculated gastric content on gastric ultrasound Immediately preoperatively
Secondary Association between duration of semaglutide therapy and 'full stomach' The correlation between duration of semaglutide therapy and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Association between duration of semaglutide therapy at current dose and 'full stomach' The correlation between duration of semaglutide therapy at current dose and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Association between duration of cessation of semaglutide and calculated gastric content The correlation between duration of cessation of semaglutide therapy and calculated gastric content on gastric ultrasound in patients administering semaglutide daily and weekly Immediately preoperatively
Secondary Association between duration of cessation of semaglutide and 'full stomach' The correlation between duration of cessation of semaglutide therapy and 'full stomach' on gastric ultrasound in patients administering semaglutide daily and weekly Immediately preoperatively
Secondary Association between preoperative blood glucose levels and calculated gastric content The correlation between preoperative blood glucose levels and calculated gastric content on gastric ultrasound Immediately preoperatively
Secondary Association between preoperative blood glucose levels and 'full stomach' The correlation between preoperative blood glucose levels and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Association between HbA1c levels and calculated gastric content The correlation between HbA1c levels and calculated gastric content on gastric ultrasound Immediately preoperatively
Secondary Association between HbA1c levels and 'full stomach' The correlation between HbA1c levels and 'full stomach' on gastric ultrasound Immediately preoperatively
Secondary Association between time since onset of diabetes mellitus and calculated gastric content The correlation between time since onset of diabetes mellitus and calculated gastric content on gastric ultrasound Immediately preoperatively
Secondary Association between time since onset of diabetes mellitus and 'full stomach' The correlation between time since onset of diabetes mellitus and 'full stomach' on gastric ultrasound Immediately preoperatively
See also
  Status Clinical Trial Phase
Completed NCT03941288 - Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia Phase 2
Terminated NCT03285308 - A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01 Phase 3
Completed NCT00733551 - Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK962040 Administered to Healthy Adult Subjects. Phase 1
Completed NCT01650714 - Endoscopic Full Thickness Biopsy, Gastric Wall. N/A
Completed NCT01452815 - Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis Phase 2
Completed NCT01039974 - GSK962040 Drug-drug Interaction Study With Ketoconazole Phase 1
Terminated NCT04844190 - Use of EndoFLIP and Manometry Prior to G-POEM N/A
Enrolling by invitation NCT06215547 - Medtronic Enterra II Neurostimulator N/A
Completed NCT04026997 - A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis Phase 2
Completed NCT00562848 - A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040 Phase 1
Enrolling by invitation NCT04207996 - Vagus Nerve Response in Gastroparesis Patients
Completed NCT04607304 - ABCA2 GIRMS Analytical Validation Clinical Performance Study N/A
Recruiting NCT06068114 - Gastric Pathophysiology in Diabetes
Completed NCT03259841 - Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy
Active, not recruiting NCT04300127 - Pioglitazone for Idiopathic Gastroparesis Early Phase 1
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3
Terminated NCT04635306 - 13C-Spirulina Nitrogen Content GEBT Study N/A
Withdrawn NCT02420925 - Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis N/A
Recruiting NCT00777439 - Domperidone for Refractory Gastrointestinal Disorders N/A
Terminated NCT00760461 - Domperidone in Refractory Gastroparesis Phase 2