CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
Magnesium sulfate +1 moredrug
Likely dose
Magnesium sulfate 50 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04638881
NCT04638881Phase 2Completed
CompareCT.gov

A Prospective, Randomized, Double-blind, Placebo-controlled Trial of the Effects of Magnesium Sulfate on Postoperative Esophageal Spasm-associated Pain Following Peroral Endoscopic Myotomy

Stanford University·interventional·Posted Nov 20, 2020·Updated May 21, 2024

In Brief

A Phase 2 clinical trial evaluating Magnesium sulfate and Normal Saline for Esophageal Spasm. Completed, enrolled 92 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Spasm
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 20, 2020
Enrollment StartDec 28, 2020
Primary CompletionApr 13, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.6 years ago

Interventions

Magnesium sulfatedrug

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

Normal Salinedrug

Placebo. Bolus and infusion administered similarly under general anesthesia.