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Magnesium for Peroral Endoscopic Myotomy (MgPOEM)

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ClinicalTrials.gov Identifier: NCT04638881
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Chi-Ho Ban Tsui, 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 reduce the incidence of postoperative pain while decreasing perioperative opioid requirements.

Condition or disease Intervention/treatment Phase
Esophageal Spasm Drug: Magnesium sulfate Drug: Normal Saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind, Placebo-controlled Trial of the Effects of Magnesium Sulfate on Postoperative Esophageal Spasm-associated Pain Following Peroral Endoscopic Myotomy
Actual Study Start Date : December 28, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Magnesium sulfate 50 mg/kg bolus + 25 mg/kg/hr infusion
Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
Drug: Magnesium sulfate
Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.

Placebo Comparator: Normal saline 0.9% 50 mg/kg bolus + 25 mg/kg/hr infusion
Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
Drug: Normal Saline
Placebo. Bolus and infusion administered similarly under general anesthesia.




Primary Outcome Measures :
  1. Esophageal Symptoms Questionnaire Score (ESQ) [ Time Frame: 0 hours postoperatively ]
    ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Responses based on a scale of 1 (Not severe) to 7 (Very severe)


Secondary Outcome Measures :
  1. Esophageal Symptoms Questionnaire Score (ESQ) [ Time Frame: 24 hours postoperatively ]
    ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Responses based on a scale of 1 (Not severe) to 7 (Very severe).

  2. Intraoperative opioid usage [ Time Frame: Between induction of anesthesia and up to 5 minutes after extubation (total estimated time frame 2 hours) ]
    Measured in intravenous fentanyl equivalents and oral morphine milliequivalents

  3. Total postoperative opioid consumption [ Time Frame: From extubation to 24 hours after extubation ]
    Measured in intravenous fentanyl equivalents and oral morphine milliequivalents

  4. Discharge opioid prescriptions [ Time Frame: At time of discharge (up to 1 minute) ]
    Measured in intravenous fentanyl equivalents and oral morphine milliequivalents



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638881


Contacts
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Contact: Richard K Kim, MD 347-586-9661 rkwkim@stanford.edu

Locations
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United States, California
Stanford Health Care Recruiting
Stanford, California, United States, 94305
Contact: Ban Tsui, MD    650-200-9107    bantsui@stanford.edu   
Contact: Chynna Villanueva, BS, RN    (650) 498-6346    chynnav@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Richard K Kim, MD Stanford University
Principal Investigator: Joo H Hwang, MD PhD Stanford University
Principal Investigator: Ban C Tsui, MD Stanford University
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Responsible Party: Chi-Ho Ban Tsui, Professor-Med Ctr Line, Stanford University
ClinicalTrials.gov Identifier: NCT04638881    
Other Study ID Numbers: 58859
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Esophageal Spasm, Diffuse
Esophageal Motility Disorders
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents