Gastric Emptying With Metoclopramide in GLP-1 Agonist Patients Undergoing Elective Surgery

NCT07100691 | Not Yet Recruiting Phase 4

• 1 other identifier: GEM-GLP1RA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicentre, investigator-blinded, randomised controlled trial evaluating whether the use of oral metoclopramide before surgery can reduce the amount of residual gastric content in patients who are taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for weight loss. These medications are known to slow down gastric emptying, which may increase the risk of pulmonary aspiration during anaesthesia. Patients will be randomly assigned to either receive metoclopramide 24 hours before surgery or continue with standard care. The primary outcome will be the presence or absence of residual gastric content on ultrasound before surgery. Secondary outcomes include nausea, vomiting, constipation, and any adverse effects of the medication.

Conditions

Pulmonary Aspiration During Anaesthetic Induction; Gastric Emptying Time; Preoperative Risk Assessment; Obesity (Disorder)

Keywords

GLP-1 Receptor Agonist; Metoclopramide; Elective Surgery; Residual Gastric Content; Gastric Ultrasound; Aspiration Risk; Perioperative Management; Obesity Medications; Randomised Controlled Trial; Anaesthesia Safety

Outcome Measures

Primary Outcomes (1)

• Presence of residual gastric content on preoperative gastric ultrasound

  Residual gastric content (RGC) will be defined as the presence of any of the following on ultrasound prior to induction of anaesthesia: (1) solid content, (2) thick fluid, or (3) clear fluid \>1.5 mL/kg in the gastric antrum. Ultrasound will be performed in the supine and right lateral decubitus positions by a blinded anaesthesiologist and reviewed by a second blinded assessor.

  On the day of surgery prior to anaesthesia induction

Secondary Outcomes (5)

• Nausea/vomiting in PACU

  2 hours

• Nausea/vomiting

  24 hours

• Constipation

  24 hours

• Adverse Reactions to Metoclopramide

  From enrollment to postoperative day 1.

• Aspiration event

  From the induction of anaesthesia to post-operative 6 hours

Study Arms (2)

Standard Care

NO INTERVENTION

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.

Metoclopramide + Standard Care

EXPERIMENTAL

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.

Drug: Metoclopramide

Interventions

Metoclopramide DRUG

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.

Also known as: Maxolon

Metoclopramide + Standard Care

Eligibility Criteria

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

You may qualify if:

• Patients taking GLP-1 receptor agonists (for weight loss only)
• 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

You may not qualify if:

• Inability to provide informed consent
• 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

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead

Study Sites (2)

National Orthopaedic Hospital Cappagh

Dublin, Dublin 5, D05K0T3, Ireland

Location

Rotunda Hospital

Dublin, Ireland

Location

Related Publications (11)

• Perlas AK, R. POCUS Spotlight: Gastric Ultrasound. ASRA News. 2021;46.

  BACKGROUND

• 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.

  PMID: 38446466 BACKGROUND

• 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.

  PMID: 39781571 BACKGROUND

• 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.

  PMID: 37234409 BACKGROUND

• 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.

  PMID: 31314613 BACKGROUND

• 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.

  PMID: 37982170 BACKGROUND

• 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.

  PMID: 37874648 BACKGROUND

• 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.

  PMID: 38298102 BACKGROUND

• 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.

  PMID: 38286487 BACKGROUND

• 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.

  PMID: 15361474 BACKGROUND

• 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.

  PMID: 21447489 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Aneurin Moorthy

  NOHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aneurin Moorthy, MB BCh BAO

CONTACT

+3531814 0400; aneurin.moorthy@gmail.com

Ryan Howle

CONTACT

ryanhowle@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators performing and interpreting the ultrasound and collecting outcome data are blinded to group allocation. Patients are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist

Model Details: Participants are randomly assigned in a 1:1 ratio to either standard care or standard care plus oral metoclopramide administered over 24 hours prior to surgery.

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: August 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2)