Magnesium for Peroral Endoscopic Myotomy

NCT04638881 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 58859
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Spasm

Outcome Measures

Primary Outcomes (1)

• 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).

  0 hours postoperatively

Secondary Outcomes (4)

• Esophageal Symptoms Questionnaire Score (ESQ)

  24 hours postoperatively

• Postoperative Opioid Consumption

  From extubation to 24 hours after extubation

• Postoperative Day 1 Opioid Consumption

  From 24 hours after extubation to 48 hours after extubation

• Average Visual Acuity Score Pain Score in Postanesthesia Care Unit

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

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Magnesium sulfate

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

PLACEBO COMPARATOR

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

Drug: Normal Saline

Interventions

Magnesium sulfate DRUG

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

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

Normal Saline DRUG

Placebo. Bolus and infusion administered similarly under general anesthesia.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Planned peroral endoscopic myotomy procedure

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Esophageal Spasm, Diffuse

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Richard K. Kim
• Organization: Stanford University School of Medicine

rkwkim@stanford.edu

3475869661

Study Officials

• Richard K Kim, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Joo H Hwang, MD PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Ban C Tsui, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: December 28, 2020
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)