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Magnesium for Peroral Endoscopic Myotomy

NCT04638881 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-05-21

Study results available
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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

Interventions

DRUG

Magnesium sulfate

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

DRUG

Normal Saline

Placebo. Bolus and infusion administered similarly under general anesthesia.

Sponsors & Collaborators

Principal Investigators

  • Richard K Kim, MD · Stanford University

  • Joo H Hwang, MD PhD · Stanford University

  • Ban C Tsui, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-28
Primary Completion
2023-04-13
Completion
2023-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638881 on ClinicalTrials.gov