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Pulmonary Aspiration During Anaesthetic InductionPhase 4GEM-GLP1RANCT07100691

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

A Phase 4 study testing Metoclopramide in people with Pulmonary Aspiration During Anaesthetic Induction and Gastric Emptying Time, run by Mater Misericordiae University Hospital at 2 sites in Ireland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Metoclopramide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesIreland
Study dates
Aug 2025to Jun 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Poorly controlled diabetes (HbA1c >69 mmol/mol)
  • Urgent or emergency surgery, including trauma
  • Diagnosis of Parkinson's disease
  • Allergy or intolerance to metoclopramide

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aneurin Moorthy, MB BCh BAO contact

+3531814 0400

aneurin.moorthy@gmail.com

Ryan Howle contact

ryanhowle@hotmail.com

Ireland2 sites
  • National Orthopaedic Hospital Cappagh

    Dublin, Dublin 5, D05K0T3

    Aneurin Moorthy, 0035318140400, aneurin.moorthy@gmail.com

  • Rotunda Hospital

    Dublin

    Ryan Howle, 0035318171700, ryanhowle@doctors.org.uk

Other trials in Ireland

About this study

Official title: Preoperative Metoclopramide to Enhance Gastric Emptying in Patients on Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss: A Randomised Controlled Trial With Ultrasound Assessment

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.

Read the detailed description

The increasing use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for weight loss has created a new challenge for anaesthesiologists: delayed gastric emptying in patients who appear to be fasted, which may increase their risk of pulmonary aspiration under anaesthesia. While consensus statements recommend assessing aspiration risk and implementing mitigation strategies, there is limited clinical trial evidence to support these practices.

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.

Being tested
Metoclopramide
Keywords
GLP-1 Receptor Agonist, Metoclopramide, Elective Surgery, Residual Gastric Content, Gastric Ultrasound, Aspiration Risk, Perioperative Management, Obesity Medications, Randomised Controlled Trial, Anaesthesia Safety
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetoclopramideDrug

    Also called Maxolon

    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.

Study groups in NCT07100691
Study groupRoleWhat they receive
Standard CareNo interventionParticipants 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 CareExperimentalParticipants 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.
Receives: Drug: Metoclopramide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: On the day of surgery prior to anaesthesia induction

Secondary outcomes (5)
  1. Nausea/vomiting in PACU

    Nausea/Vomiting

    Measured: 2 hours

  2. Nausea/vomiting

    Nausea/vomiting

    Measured: 24 hours

  3. Constipation

    Constipation

    Measured: 24 hours

  4. Adverse Reactions to Metoclopramide

    Adverse Reactions to Metoclopramide

    Measured: From enrollment to postoperative day 1.

  5. Aspiration event

    Aspiration of gastric contents

    Measured: From the induction of anaesthesia to post-operative 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07100691
Sponsor's protocol ID
GEM-GLP1RA
Acronym
GEM-GLP1RA
Status last verified
Aug 2025
First submitted
27 Jul 2025
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to the limited scale of the study, the absence of an established data-sharing infrastructure, and institutional constraints regarding the release of health-related data beyond the study team. Any future sharing of anonymized data will require separate ethical approval and data access agreements.

Publications

  • 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.

    PubMed 38446466
  • 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.

    PubMed 39781571
  • 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.

    PubMed 37234409
  • 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.

    PubMed 31314613
  • 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.

    PubMed 37982170
  • 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.

    PubMed 37874648
  • 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.

    PubMed 38298102
  • 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.

    PubMed 38286487
  • 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.

    PubMed 15361474
  • 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.

    PubMed 21447489

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metoclopramide in people with Pulmonary Aspiration During Anaesthetic Induction and Gastric Emptying Time, run by Mater Misericordiae University Hospital at 2 sites in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aneurin Moorthy, MB BCh BAO (+3531814 0400, aneurin.moorthy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of residual gastric content on preoperative gastric ultrasound (time frame: On the day of surgery prior to anaesthesia induction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07100691, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

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