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Gastric Emptying With Metoclopramide in GLP-1 Agonist Patients Undergoing Elective Surgery (GEM-GLP1RA) Phase 4 80

Not yet recruiting
Clinical Trial NCT07100691 (GEM-GLP1RA) is designed to study Treatment for Pulmonary Aspiration During Anaesthetic Induction, Gastric Emptying Time, Preoperative Risk Assessment, Obesity (Disorder). This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on August 1, 2025 until the study accrues 80 participants. Led by Mater Misericordiae University Hospital, this study is expected to complete by June 1, 2026. The latest data from ClinicalTrials.gov was last updated on August 6, 2025.
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. Pat...Show More
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 eviden...Show More
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

Conditions
Pulmonary Aspiration During Anaesthetic InductionGastric Emptying TimePreoperative Risk AssessmentObesity (Disorder)
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • GEM-GLP1RA
NCT ID Number
NCT07100691
Start Date (Actual)
2025-08
Last Update Posted
2025-08-06
Completion Date (Estimated)
2026-06
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
GLP-1 Receptor Agonist
Metoclopramide
Elective Surgery
Residual Gastric Content
Gastric Ultrasound
Aspiration Risk
Perioperative Management
Obesity Medications
Randomised Controlled Trial
Anaesthesia Safety
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No InterventionStandard 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.
N/A
ExperimentalMetoclopramide + 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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Nausea/vomiting in PACU
Nausea/Vomiting
2 hours
Nausea/vomiting
Nausea/vomiting
24 hours
Constipation
Constipation
24 hours
Adverse Reactions to Metoclopramide
Adverse Reactions to Metoclopramide
From enrollment to postoperative day 1.
Aspiration event
Aspiration of gastric contents
From the induction of anaesthesia to post-operative 6 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Mater Misericordiae University Hospital logoMater Misericordiae University Hospital
Study Responsible Party
Aneurin Moorthy, Principal Investigator, Consultant Anaesthesiologist, Mater Misericordiae University Hospital
Study Central Contact
Contact: Aneurin Moorthy, MB BCh BAO, +3531814 0400, [email protected]
Contact: Ryan Howle, [email protected]
2 Study Locations in 1 Countries

Dublin 5

National Orthopaedic Hospital Cappagh, Dublin, Dublin 5, D05K0T3, Ireland
Aneurin Moorthy, Contact, 0035318140400, [email protected]
Rotunda Hospital, Dublin, Ireland
Ryan Howle, Contact, 0035318171700, [email protected]