Magnesium for Peroral Endoscopic Myotomy

Phase 2

Completed

• Conditions: Esophageal Spasm
• Interventions: Drug: Magnesium sulfate; Drug: Normal Saline

• Registration Number: NCT04638881
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Study Start: 2020-12-28
• Primary Completion: 2023-04-13
• Study Completion: 2023-04-13
• Results First Submitted: 2024-03-12
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Results First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium sulfate 50 mg/kg bolus + 25 mg/kg/hr infusion	Magnesium sulfate	Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
Normal saline 0.9% 50 mg/kg bolus + 25 mg/kg/hr infusion	Normal Saline	Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.

Primary Outcome Measures

Name	Time	Method
Esophageal Symptoms Questionnaire Score (ESQ)	0 hours postoperatively	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).

Secondary Outcome Measures

Name	Time	Method
Esophageal Symptoms Questionnaire Score (ESQ)	24 hours postoperatively	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).
Postoperative Opioid Consumption	From extubation to 24 hours after extubation	Measured in oral morphine milliequivalents
Postoperative Day 1 Opioid Consumption	From 24 hours after extubation to 48 hours after extubation	Measured in oral morphine milliequivalents
Average Visual Acuity Score Pain Score in Postanesthesia Care Unit	From extubation to discharge from postanesthesia care unit (up to 4 hours)	Pain measuring scale based on scale from 0 (no pain) to 10 (severe pain).

Trial Locations

Locations (1)

Stanford Health Care; 🇺🇸 Stanford, California, United States