Magnesium for Peroral Endoscopic Myotomy (MgPOEM)

Stanford University

Status and phase: Completed; Phase 2

Conditions: Esophageal Spasm

Treatments: Drug: Normal Saline; Drug: Magnesium sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04638881

58859

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups, including a placebo group

Magnesium sulfate 50 mg/kg bolus + 25 mg/kg/hr infusion

Experimental group

Description:

Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.

Treatment:

Drug: Magnesium sulfate

Normal saline 0.9% 50 mg/kg bolus + 25 mg/kg/hr infusion

Placebo Comparator group

Description:

Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.

Treatment:

Drug: Normal Saline