NCT07616908

Brief Summary

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Jun 2028

First Submitted

Initial submission to the registry

May 17, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

May 17, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

residual gastric volumemiralaxpolythylene glycolgastric POCUSpediatricEGDcolonoscopy

Outcome Measures

Primary Outcomes (1)

  • Residual gastric volume as measured by EGD

    To be performed at the start of the EGD immediately after anesthesia induction.

Secondary Outcomes (3)

  • Preoperative gastric POCUS volume assessment

    Performed prior to anesthesia induction

  • Effectiveness of colonoscopy cleanout

    Performed during the colonoscopy portion following upper GI endoscopy (EGD)

  • Incidence of aspiration on induction and perioperative aspiration

    On anesthesia induction

Study Arms (4)

4hr NPO

ACTIVE COMPARATOR

Miralax will be stopped 4 hours prior anesthesia induction

Behavioral: Stopping Miralax ingestion 4 hours prior to anesthesia induction

6hr NPO

ACTIVE COMPARATOR

Miralax will be stopped 6 hours prior anesthesia induction

Behavioral: Stopping Miralax ingestion 6 hours prior to anesthesia induction

2hr NPO

ACTIVE COMPARATOR

Miralax will be stopped 2 hours prior anesthesia induction

Behavioral: Stopping Miralax ingestion 2 hours prior to anesthesia induction

Control

ACTIVE COMPARATOR

Miralax will not be given day of surgery

Behavioral: Control

Interventions

Stopping Miralax ingestion 2 hours prior to anesthesia induction

2hr NPO

Stopping Miralax ingestion 4 hours prior to anesthesia induction

4hr NPO

Stopping Miralax ingestion 6 hours prior to anesthesia induction

6hr NPO
ControlBEHAVIORAL

Miralax will not be given on the day of surgery

Control

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The endoscopist, the anesthesiologist performing the gastric POCUS evaluation, the anesthesiologist, the research coordinator
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

May 17, 2026

First Posted

June 1, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

July 6, 2026

Record last verified: 2026-07