Magnesium for Peroral Endoscopic Myotomy (MgPOEM)

A Prospective, Randomized, Double-blind, Placebo-controlled Trial of the Effects of Magnesium Sulfate on Postoperative Esophageal Spasm-associated Pain Following Peroral Endoscopic Myotomy

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Spasm
• Intervention / Treatment: Drug: Magnesium sulfate; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Richard K Kim, MD; Phone Number: 347-586-9661; Email: rkwkim@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnesium sulfate 50 mg/kg bolus + 25 mg/kg/hr infusion; Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.	Drug: Magnesium sulfate; Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.
Placebo Comparator: Normal saline 0.9% 50 mg/kg bolus + 25 mg/kg/hr infusion; Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.	Drug: Normal Saline; Placebo. Bolus and infusion administered similarly under general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	0 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 hours postoperatively
Postoperative opioid consumption	Measured in oral morphine milliequivalents	From extubation to 24 hours after extubation
Postoperative day 1 opioid consumption	Measured in oral morphine milliequivalents	From 24 hours after extubation to 48 hours after extubation
Average Visual Acuity Score Pain Score in postanesthesia care unit	Pain measuring scale based on scale from 0 (no pain) to 10 (severe pain).	From extubation to discharge from postanesthesia care unit (up to 4 hours)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Richard K Kim, MD, Stanford University; Principal Investigator: Joo H Hwang, MD PhD, Stanford University; Principal Investigator: Ban C Tsui, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Neuromuscular Manifestations; Deglutition Disorders; Esophageal Diseases; Spasm; Esophageal Motility Disorders; Esophageal Spasm, Diffuse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: 58859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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