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Trial · Interventional

Not yet recruitingPhase 4Registry data

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

Short name GEM-GLP1RA

NCTNCT07100691 (opens ClinicalTrials.gov in a new tab)Other idGEM-GLP1RA
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Glucagon, does not test it. It appears in the title.

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
80 participants (estimated)
Sponsor
Mater Misericordiae University Hospital · Other
Design
Randomized · Double masking
Countries
1 country

Ireland

Start
Aug 2025 (estimated)
Primary completion
May 2026 (estimated)
Completion
Jun 2026 (estimated)
First posted
3 Aug 2025
Last update posted
6 Aug 2025
Conditions
Pulmonary Aspiration During Anaesthetic Induction · Gastric Emptying Time · Preoperative Risk Assessment · Obesity (Disorder)

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 4

    GEM-GLP1RA

    NCT07100691

    est. Aug 2025 to est. Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • MetoclopramideDrug

Arms2

  • No intervention

    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.

  • Experimental

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Presence of residual gastric content on preoperative gastric ultrasound

    Time frame · On the day of surgery prior to anaesthesia induction

    Registry description

    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.

Secondary outcomes(5)

  1. Nausea/vomiting in PACU

    Time frame · 2 hours

    Registry description

    Nausea/Vomiting

  2. Nausea/vomiting

    Time frame · 24 hours

    Registry description

    Nausea/vomiting

  3. Constipation

    Time frame · 24 hours

    Registry description

    Constipation

  4. Adverse Reactions to Metoclopramide

    Time frame · From enrollment to postoperative day 1.

    Registry description

    Adverse Reactions to Metoclopramide

  5. Aspiration event

    Time frame · From the induction of anaesthesia to post-operative 6 hours

    Registry description

    Aspiration of gastric contents

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Systematic review · 2024

11 results

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.

Yao et al. 2024BMJ (Clinical research ed.)cited by 449

PMID 38286487PMC10823535DOI 10.1136/bmj-2023-076410PUB-38286487

Free to read · publisher termsCC BY-NC11 results
Read at sourceSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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