- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07616908
Effect of Miralax NPO Time on Residual Gastric Volumes and Bowel Preparation
July 1, 2026 updated by: Stephanie Jiaying Pan, Stanford University
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).
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 4hr NPO
Miralax will be stopped 4 hours prior anesthesia induction
|
Stopping Miralax ingestion 4 hours prior to anesthesia induction
|
|
Active Comparator: 2hr NPO
Miralax will be stopped 2 hours prior anesthesia induction
|
Stopping Miralax ingestion 2 hours prior to anesthesia induction
|
|
Active Comparator: 6hr NPO
Miralax will be stopped 6 hours prior anesthesia induction
|
Stopping Miralax ingestion 6 hours prior to anesthesia induction
|
|
Active Comparator: Control
Miralax will not be given day of surgery
|
Miralax will not be given on the day of surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Residual gastric volume as measured by EGD
Time Frame: To be performed at the start of the EGD immediately after anesthesia induction.
|
To be performed at the start of the EGD immediately after anesthesia induction.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative gastric POCUS volume assessment
Time Frame: Performed prior to anesthesia induction
|
Performed prior to anesthesia induction
|
|
|
Effectiveness of colonoscopy cleanout
Time Frame: Performed during the colonoscopy portion following upper GI endoscopy (EGD)
|
The effectiveness of colonoscopy cleanout will be assessed by the Boston Bowel Preparation Scale (BBPS).
|
Performed during the colonoscopy portion following upper GI endoscopy (EGD)
|
|
Incidence of aspiration on induction and perioperative aspiration
Time Frame: On anesthesia induction
|
On anesthesia induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
May 17, 2026
First Submitted That Met QC Criteria
May 26, 2026
First Posted (Actual)
June 1, 2026
Study Record Updates
Last Update Posted (Actual)
July 6, 2026
Last Update Submitted That Met QC Criteria
July 1, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 86683
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.