Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2020-12-28
2023-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Magnesium sulfate
Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.
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.
Normal Saline
Placebo. Bolus and infusion administered similarly under general anesthesia.
Interventions
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Magnesium sulfate
Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.
Normal Saline
Placebo. Bolus and infusion administered similarly under general anesthesia.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Richard K. Kim
Clinical Assistant Professor
Principal Investigators
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Richard K Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Joo H Hwang, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Ban C Tsui, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Health Care
Stanford, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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58859
Identifier Type: -
Identifier Source: org_study_id
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