Gastric Emptying With Metoclopramide in GLP-1 Agonist Patients Undergoing Elective Surgery
NCT ID: NCT07100691
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2025-08-31
2026-06-30
Brief Summary
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Detailed Description
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This is a multicentre, prospective, single-blinded, randomised controlled trial designed to assess whether preoperative oral metoclopramide can reduce residual gastric content (RGC) in patients taking GLP-1 RAs prior to elective surgery. Eighty adult patients who are taking GLP-1 RAs for weight loss will be enrolled and randomly assigned in a 1:1 ratio to either standard care or standard care plus metoclopramide. Standard care is defined as continuation of GLP-1 RA medications as per current perioperative guidance. The intervention group will receive four doses of oral metoclopramide 10 mg: three doses the day before surgery and one dose on the morning of surgery.
The primary outcome for this randomised controlled trial will be the presence of residual gastric content (RGC) \[yes/no\] on gastric ultrasound examination in fasting patients taking GLP-1 agonists, scheduled for elective surgery. Our primary outcome will be a binary outcome, and we will define the presence of RGC as one or more of the following present on gastric ultrasound examination: 1. Presence of solid; 2. Presence thick fluid; and 3. \> 1.5ml/kg of clear fluid.
Based on a recent published prospective cross-sectional study, the prevalence of increased RGC in patients taking GLP-1 agonist was 56% and the authors found that the absolute effect on RGC in patients taking GLP-1 agonists was 30% (i.e., increasing the chance of gastric contents by 30%) (11). Therefore, we propose that in the intervention group to reduce the prevalence of RGC to 25% to be clinically meaningful. Assuming Type 1 error = 0.05 and Type 2 error = 0.1 (80% power to detect this difference), then n= 36 patients will be required in each group. To accommodate for 10% participants who may withdraw from the study, we will aim to recruit n= 40 participants to each study arm, i.e. n=80 in total. Sample size calculation was verified using an online calculator (https://www.sealedenvelope.com/power/binary-superiority/)
Statistical analysis will be conducted on an intention-to-treat basis using appropriate tests for binary and continuous variables.
This trial aims to address the evidence gap in perioperative management of patients taking GLP-1 RAs and to evaluate whether a simple pharmacologic intervention with metoclopramide can safely reduce aspiration risk in this growing patient population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard Care
Participants in this arm will continue their usual glucagon-like peptide-1 receptor agonist (GLP-1 RA) medication before surgery, in line with current perioperative guidance. No additional medications will be administered. Gastric ultrasound will be performed on the morning of surgery to assess residual gastric content.
No interventions assigned to this group
Metoclopramide + Standard Care
Participants in this arm will continue their usual GLP-1 RA medication and also receive four oral doses of metoclopramide 10 mg: three doses the day before surgery and one dose on the morning of surgery. This intervention is intended to enhance gastric emptying and reduce residual gastric content, which will be assessed via gastric ultrasound on the morning of surgery.
Metoclopramide
Oral metoclopramide 10 mg, administered as three doses the day before surgery and one dose on the morning of surgery (total four doses over 24 hours). Used to enhance gastric emptying in patients taking GLP-1 receptor agonists.
Interventions
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Metoclopramide
Oral metoclopramide 10 mg, administered as three doses the day before surgery and one dose on the morning of surgery (total four doses over 24 hours). Used to enhance gastric emptying in patients taking GLP-1 receptor agonists.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female patients aged 18 years or older
* Able to provide written informed consent
* ASA grade I-V
* Scheduled for elective surgery with an expected overnight hospital stay
Exclusion Criteria
* Presence of hiatus hernia
* History of any gastric surgery
* Pregnancy
* Inability to lie in the right lateral decubitus position
* Patients taking chronic opioids
* Poorly controlled diabetes (HbA1c \>69 mmol/mol)
* Urgent or emergency surgery, including trauma
* Diagnosis of Parkinson's disease
* Allergy or intolerance to metoclopramide
18 Years
ALL
No
Sponsors
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Mater Misericordiae University Hospital
OTHER
Responsible Party
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Aneurin Moorthy
Consultant Anaesthesiologist
Principal Investigators
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Aneurin Moorthy
Role: PRINCIPAL_INVESTIGATOR
NOHC
Locations
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National Orthopaedic Hospital Cappagh
Dublin, Dublin 5, Ireland
Rotunda Hospital
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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References
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Perlas AK, R. POCUS Spotlight: Gastric Ultrasound. ASRA News. 2021;46.
Sen S, Potnuru PP, Hernandez N, Goehl C, Praestholm C, Sridhar S, Nwokolo OO. Glucagon-Like Peptide-1 Receptor Agonist Use and Residual Gastric Content Before Anesthesia. JAMA Surg. 2024 Jun 1;159(6):660-667. doi: 10.1001/jamasurg.2024.0111.
El-Boghdadly K, Dhesi J, Fabb P, Levy N, Lobo DN, McKechnie A, Mustafa O, Newland-Jones P, Patel A, Pournaras DJ, Clare K, Dhatariya K. Elective peri-operative management of adults taking glucagon-like peptide-1 receptor agonists, glucose-dependent insulinotropic peptide agonists and sodium-glucose cotransporter-2 inhibitors: a multidisciplinary consensus statement: A consensus statement from the Association of Anaesthetists, Association of British Clinical Diabetologists, British Obesity and Metabolic Surgery Society, Centre for Perioperative Care, Joint British Diabetes Societies for Inpatient Care, Royal College of Anaesthetists, Society for Obesity and Bariatric Anaesthesia and UK Clinical Pharmacy Association. Anaesthesia. 2025 Apr;80(4):412-424. doi: 10.1111/anae.16541. Epub 2025 Jan 9.
Lin H, He JJ, Cai ZS, Lu ZW, Lin ZJ, Lin XZ, Huang QW. Ultrasonic evaluation of metoclopramide's effect on gastric motility in emergency trauma patients. Front Physiol. 2023 May 10;14:999736. doi: 10.3389/fphys.2023.999736. eCollection 2023.
Shakhatreh M, Jehangir A, Malik Z, Parkman HP. Metoclopramide for the treatment of diabetic gastroparesis. Expert Rev Gastroenterol Hepatol. 2019 Aug;13(8):711-721. doi: 10.1080/17474124.2019.1645594. Epub 2019 Jul 30.
Ushakumari DS, Sladen RN. ASA Consensus-based Guidance on Preoperative Management of Patients on Glucagon-like Peptide-1 Receptor Agonists. Anesthesiology. 2024 Feb 1;140(2):346-348. doi: 10.1097/ALN.0000000000004776. No abstract available.
Joshi GP. Anesthetic Considerations in Adult Patients on Glucagon-Like Peptide-1 Receptor Agonists: Gastrointestinal Focus. Anesth Analg. 2024 Jan 1;138(1):216-220. doi: 10.1213/ANE.0000000000006810. Epub 2023 Dec 15. No abstract available.
Gariani K, Putzu A. Glucagon-like peptide-1 receptor agonists in the perioperative period: Implications for the anaesthesiologist. Eur J Anaesthesiol. 2024 Mar 1;41(3):245-246. doi: 10.1097/EJA.0000000000001914. Epub 2024 Feb 2. No abstract available.
Yao H, Zhang A, Li D, Wu Y, Wang CZ, Wan JY, Yuan CS. Comparative effectiveness of GLP-1 receptor agonists on glycaemic control, body weight, and lipid profile for type 2 diabetes: systematic review and network meta-analysis. BMJ. 2024 Jan 29;384:e076410. doi: 10.1136/bmj-2023-076410.
Asai T. Editorial II: Who is at increased risk of pulmonary aspiration? Br J Anaesth. 2004 Oct;93(4):497-500. doi: 10.1093/bja/aeh234. No abstract available.
Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.
Other Identifiers
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GEM-GLP1RA
Identifier Type: -
Identifier Source: org_study_id
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