Phase 2
N=92
Magnesium for Peroral Endoscopic Myotomy
Esophageal Spasm
Bottom Line
View on ClinicalTrials.gov: NCT04638881 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Esophageal Symptoms Questionnaire Score (ESQ) — 24; 35 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Magnesium sulfate (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Esophageal Symptoms Questionnaire Score (ESQ) |
16; 30 | — |
| SECONDARY Esophageal Symptoms Questionnaire Score (ESQ) |
16; 30 | — |
| SECONDARY Postoperative Opioid Consumption |
0; 30 | — |
| SECONDARY Postoperative Day 1 Opioid Consumption |
0; 6 | — |
| SECONDARY Average Visual Acuity Score Pain Score in Postanesthesia Care Unit |
0; 5 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04638881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.