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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMater Misericordiae University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to provide informed consent

Presence of hiatus hernia

History of any gastric surgery

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Standard CareNo intervention 0 interventions
Group B: Metoclopramide + Standard CareExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
On the day of surgery prior to anaesthesia induction

Secondary outcomes

1

Nausea/vomiting in PACU

Nausea/Vomiting

Time frame
2 hours
2

Nausea/vomiting

Nausea/vomiting

Time frame
24 hours
3

Constipation

Constipation

Time frame
24 hours
4

Adverse Reactions to Metoclopramide

Adverse Reactions to Metoclopramide

Time frame
From enrollment to postoperative day 1.

Other outcomes

Sponsors and contacts

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