MgPOEM: Magnesium for Peroral Endoscopic Myotomy

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04638881

Collaborator

(none)

100

Enrollment

Location

Arms

24.1

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 28, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Esophageal Symptoms Questionnaire Score (ESQ) [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

Esophageal Symptoms Questionnaire Score (ESQ) [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).
Intraoperative opioid usage [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
Total postoperative opioid consumption [From extubation to 24 hours after extubation]
Measured in intravenous fentanyl equivalents and oral morphine milliequivalents
Discharge opioid prescriptions [At time of discharge (up to 1 minute)]
Measured in intravenous fentanyl equivalents and oral morphine milliequivalents

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Health Care	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chi-Ho Ban Tsui, Professor-Med Ctr Line, Stanford University

ClinicalTrials.gov Identifier:

NCT04638881

Other Study ID Numbers:

58859

First Posted:

Nov 20, 2020

Last Update Posted:

Jun 14, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Esophageal Spasm, Diffuse

Esophageal Motility Disorders

Spasm

Magnesium Sulfate

Study Results

No Results Posted as of Jun 14, 2022