Skip to main content
OpenTrials
Completed

NCT Number: NCT04638881

Magnesium for 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Esophageal Spasm Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Esophageal Spasm, Diffuse Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford Health Care

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Magnesium sulfate

Drug

Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.

normal saline

Drug

Placebo. Bolus and infusion administered similarly under general anesthesia.

Primary outcomes

  1. Esophageal Symptoms Questionnaire Score (ESQ)

    Time frame: 0 hours postoperatively

    ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Participants answer 11 questions, each rated on a scale of 1 (Not severe) to 7 (Very severe). Scores were summed for an overall score (range 11 to 77, higher scores indicate more severe dysphagia).

Secondary outcomes

  1. Esophageal Symptoms Questionnaire Score (ESQ)

    Time frame: 24 hours postoperatively

    ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Participants answer 11 questions, each rated on a scale of 1 (Not severe) to 7 (Very severe). Scores were summed for an overall score (range 11 to 77, higher scores indicate more severe dysphagia).

  2. Postoperative Opioid Consumption

    Time frame: From extubation to 24 hours after extubation

    Measured in oral morphine milliequivalents

  3. Postoperative Day 1 Opioid Consumption

    Time frame: From 24 hours after extubation to 48 hours after extubation

    Measured in oral morphine milliequivalents

  4. Average Visual Acuity Score Pain Score in Postanesthesia Care Unit

    Time frame: From extubation to discharge from postanesthesia care unit (up to 4 hours)

    Pain measuring scale based on scale from 0 (no pain) to 10 (severe pain).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Acronym: MgPOEM

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 20, 2020
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.