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Recruiting NCT07006142

Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists

No phase Interventional Upper Endoscopy GLP1-R-related Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modified Fasting Guidelines.
Who it may be relevant to
Registry conditions: Upper Endoscopy, GLP1-R-related Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The aim of this study is to determine whether a modified fasting protocol can reduce the potential risk of aspiration for patients currently prescribed GLP1-RAs.

Detailed description

The overall objective of this project is to identify a reasonable means by which patients on GLP1-RAs can be safely cared for in the perioperative period that can be agreed upon by all groups involved in perioperative patient care. This will be assessed in patients undergoing upper endoscopy specifically since assessment of gastric contents would be minimally invasive for this patient population receiving anesthetic care.

Interventions

  • Other Modified Fasting Guidelines
    Patients will follow a full-liquid diet 48 hours prior to their procedure, clear liquid diet 24 hours prior to their procedure, and nothing by mouth (NPO) after midnight on the day of their procedure

Primary outcome measures

  • Gastric contents [Time frame: Baseline]
Secondary outcome measures (3)
  • Diagnosis of aspiration within 72 hours of procedure [Time frame: From the time of upper endoscopy until 72 hours post-procedure.]
  • Aspiration pneumonitis diagnosis postoperatively [Time frame: 72 hours after completion of upper endoscopy]
  • Postprocedural ICU admission [Time frame: Immediately after upper endoscopy]

Eligibility criteria

Inclusion criteria

  • Patients undergoing elective upper endoscopy with gastroenterology team

Exclusion criteria

  • Urgent or emergent procedure
  • Inclusion of colonoscopy or antegrade small bowel enteroscopy in planned procedure
  • Upper GI barium study performed in past 24 hours.
  • Gastroparesis
  • Achalasia
  • Pancreatitis
  • Use of outpatient pro-motility medications
  • Patient refusal
  • Inability for patient to provide own consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07006142 · 23-013192

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗