Phase 2
Completed N=92
Magnesium for Peroral Endoscopic Myotomy
Esophageal Spasm
Source: ClinicalTrials.gov NCT04638881 ↗
Enrolled (actual)
92
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Esophageal Symptoms Questionnaire Score (ESQ) — 24; 35 score on a scale
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.
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 | — |
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. Informational only — not medical advice.