Magnesium for Peroral Endoscopic Myotomy

Stanford University92 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Esophageal Spasm

Interventions

Magnesium sulfateDRUG

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

Normal SalineDRUG

Placebo. Bolus and infusion administered similarly under general anesthesia.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Stanford Health Care

Stanford, California, United States

Outcomes

Primary Outcomes

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).

Time frame: 0 hours postoperatively

Secondary Outcomes

Esophageal Symptoms Questionnaire Score (ESQ)

Time frame: 24 hours postoperatively

Postoperative Opioid Consumption

Measured in oral morphine milliequivalents

Time frame: From extubation to 24 hours after extubation

Postoperative Day 1 Opioid Consumption

Measured in oral morphine milliequivalents

Time frame: 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).

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

Data from ClinicalTrials.gov

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