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Not yet recruiting NCT07616908

Effect of Miralax NPO Time on Residual Gastric Volumes and Bowel Preparation

No phase Interventional Residual Gastric Contents Polyethylene Glycol

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: Stopping Miralax ingestion 4 hours prior to anesthesia induction, Stopping Miralax ingestion 6 hours prior to anesthesia induction, Stopping Miralax ingestion 2 hours prior to anesthesia induction, Control.
Who it may be relevant to
Registry conditions: Residual Gastric Contents, Polyethylene Glycol. Basic parameters: up to 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this clinical trial is to assess differences in residual gastric volumes after stopping Miralax ingestion at different time points (2, 4, 6 hours) prior to anesthesia induction and compare it to the control (current institutional standard of care where no Miralax is given on the day of surgery).

Interventions

  • Behavioral Stopping Miralax ingestion 4 hours prior to anesthesia induction
    Stopping Miralax ingestion 4 hours prior to anesthesia induction
  • Behavioral Stopping Miralax ingestion 6 hours prior to anesthesia induction
    Stopping Miralax ingestion 6 hours prior to anesthesia induction
  • Behavioral Stopping Miralax ingestion 2 hours prior to anesthesia induction
    Stopping Miralax ingestion 2 hours prior to anesthesia induction
  • Behavioral Control
    Miralax will not be given on the day of surgery

Primary outcome measures

  • Residual gastric volume as measured by EGD [Time frame: To be performed at the start of the EGD immediately after anesthesia induction.]
Secondary outcome measures (3)
  • Preoperative gastric POCUS volume assessment [Time frame: Performed prior to anesthesia induction]
  • Effectiveness of colonoscopy cleanout [Time frame: Performed during the colonoscopy portion following upper GI endoscopy (EGD)]
  • Incidence of aspiration on induction and perioperative aspiration [Time frame: On anesthesia induction]

Eligibility criteria

Inclusion criteria

  • Patients undergoing both EGD and colonoscopy
  • Use of Miralax for cleanout
  • Patients <19 years old

Exclusion criteria

  • Patients with a history of delayed gastric emptying (eg diabetic, GLP-1 intake)
  • Patients with a history of gastric sleeve surgery
  • Use of Golytely for cleanout
  • Emergent EGD/colonoscopies
  • EGD/colonoscopies for foreign body removal and/or decompression
  • Known neurologic compromise
  • Presence of pre-existing ostomy, short bowel syndrome, gastric retention, intestinal obstruction, ileus, bowel perforation, toxic colitis, toxic megacolon, swallowing difficulties
  • Pre-existing electrolyte derangements
  • Allergy to Miralax

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07616908 · 86683

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗