Back to resultsMagnesium for Peroral Endoscopic Myotomy (MgPOEM)
Primary Purpose
Esophageal Spasm
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Magnesium sulfate
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Spasm
Eligibility Criteria
Inclusion Criteria:
- Planned peroral endoscopic myotomy procedure
Exclusion Criteria:
- cannot give consent
- patients who are clinically unstable and/or require urgent/emergent intervention
- previous esophageal myotomy
- preexisting hypermagnesemia
- end-stage renal disease
- neuromuscular disease, including but not limited to Guillain-Barre syndrome, myasthenia gravis, congenital myopathy, and muscular dystrophy
- preexisting heart failure
- severe ventricular systolic dysfunction (left or right ventricle)
Sites / Locations
- Stanford Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Magnesium sulfate 50 mg/kg bolus + 25 mg/kg/hr infusion
Normal saline 0.9% 50 mg/kg bolus + 25 mg/kg/hr infusion
Arm Description
Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
Outcomes
Primary Outcome Measures
Esophageal Symptoms Questionnaire Score (ESQ)
ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Responses based on a scale of 1 (Not severe) to 7 (Very severe)
Secondary Outcome Measures
Esophageal Symptoms Questionnaire Score (ESQ)
ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Responses based on a scale of 1 (Not severe) to 7 (Very severe).
Postoperative opioid consumption
Measured in oral morphine milliequivalents
Postoperative day 1 opioid consumption
Measured in oral morphine milliequivalents
Average Visual Acuity Score Pain Score in postanesthesia care unit
Pain measuring scale based on scale from 0 (no pain) to 10 (severe pain).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04638881
Brief Title
Magnesium for Peroral Endoscopic Myotomy
Acronym
MgPOEM
Official Title
A Prospective, Randomized, Double-blind, Placebo-controlled Trial of the Effects of Magnesium Sulfate on Postoperative Esophageal Spasm-associated Pain Following Peroral Endoscopic Myotomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
April 13, 2023 (Actual)
Study Completion Date
April 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Postoperative pain after peroral endoscopic myotomy occurs due to involuntary esophageal smooth muscle spasms. Magnesium has antispasmodic properties as a smooth muscle relaxant. This study hypothesizes that among patients having peroral endoscopic myotomy, magnesium will decrease postoperative esophgeal pain as measured by the esophageal symptoms questionnaire, while decreasing perioperative opioid requirements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Spasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium sulfate 50 mg/kg bolus + 25 mg/kg/hr infusion
Arm Type
Experimental
Arm Description
Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
Arm Title
Normal saline 0.9% 50 mg/kg bolus + 25 mg/kg/hr infusion
Arm Type
Placebo Comparator
Arm Description
Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Placebo. Bolus and infusion administered similarly under general anesthesia.
Primary Outcome Measure Information:
Title
Esophageal Symptoms Questionnaire Score (ESQ)
Description
ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Responses based on a scale of 1 (Not severe) to 7 (Very severe)
Time Frame
0 hours postoperatively
Secondary Outcome Measure Information:
Title
Esophageal Symptoms Questionnaire Score (ESQ)
Description
ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Responses based on a scale of 1 (Not severe) to 7 (Very severe).
Time Frame
24 hours postoperatively
Title
Postoperative opioid consumption
Description
Measured in oral morphine milliequivalents
Time Frame
From extubation to 24 hours after extubation
Title
Postoperative day 1 opioid consumption
Description
Measured in oral morphine milliequivalents
Time Frame
From 24 hours after extubation to 48 hours after extubation
Title
Average Visual Acuity Score Pain Score in postanesthesia care unit
Description
Pain measuring scale based on scale from 0 (no pain) to 10 (severe pain).
Time Frame
From extubation to discharge from postanesthesia care unit (up to 4 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Planned peroral endoscopic myotomy procedure
Exclusion Criteria:
cannot give consent
patients who are clinically unstable and/or require urgent/emergent intervention
previous esophageal myotomy
preexisting hypermagnesemia
end-stage renal disease
neuromuscular disease, including but not limited to Guillain-Barre syndrome, myasthenia gravis, congenital myopathy, and muscular dystrophy
preexisting heart failure
severe ventricular systolic dysfunction (left or right ventricle)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard K Kim, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joo H Hwang, MD PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ban C Tsui, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Magnesium for Peroral Endoscopic Myotomy
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