Magnesium for Peroral Endoscopic Myotomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophageal Spasm

Intervention / Treatment
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* Drug: Magnesium sulfate
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) |