Magnesium for Peroral Endoscopic Myotomy

Esophageal Spasm Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638881
• Other study ID #: 58859
• Status: Completed
• Phase: Phase 2
• Start date: December 28, 2020
• Est. completion date: April 13, 2023

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 13, 2023
• Est. primary completion date: April 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Esophageal Motility Disorders
• Esophageal Spasm
• Esophageal Spasm, Diffuse
• Spasm

Intervention

Drug:
• Magnesium sulfate
Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.
• Normal Saline
Placebo. Bolus and infusion administered similarly under general anesthesia.

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal Symptoms Questionnaire Score (ESQ)	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).	0 hours postoperatively
Secondary	Esophageal Symptoms Questionnaire Score (ESQ)	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).	24 hours postoperatively
Secondary	Postoperative Opioid Consumption	Measured in oral morphine milliequivalents	From extubation to 24 hours after extubation
Secondary	Postoperative Day 1 Opioid Consumption	Measured in oral morphine milliequivalents	From 24 hours after extubation to 48 hours after extubation
Secondary	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)