A Phase 2 interventional study of Magnesium sulfate and Normal Saline in Esophageal Spasm, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Stanford University · Phase 2, Interventional, and Treatment
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.
7 studies on the registry are indexed under Esophageal Spasm, Diffuse; 1 is open to participants now.
Browse Esophageal Spasm, Diffuse studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
Drug: Magnesium sulfate
Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
Drug: Normal Saline
Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.
Placebo. Bolus and infusion administered similarly under general anesthesia.
Esophageal Symptoms Questionnaire Score (ESQ)
ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Participants answer 11 questions, each rated on a scale of 1 (Not severe) to 7 (Very severe). Scores were summed for an overall score (range 11 to 77, higher scores indicate more severe dysphagia).
Time frame: 0 hours postoperatively
Esophageal Symptoms Questionnaire Score (ESQ)
ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Participants answer 11 questions, each rated on a scale of 1 (Not severe) to 7 (Very severe). Scores were summed for an overall score (range 11 to 77, higher scores indicate more severe dysphagia).
Time frame: 24 hours postoperatively
Postoperative Opioid Consumption
Measured in oral morphine milliequivalents
Time frame: From extubation to 24 hours after extubation
Postoperative Day 1 Opioid Consumption
Measured in oral morphine milliequivalents
Time frame: From 24 hours after extubation to 48 hours after extubation
Average Visual Acuity Score Pain Score in Postanesthesia Care Unit
Pain measuring scale based on scale from 0 (no pain) to 10 (severe pain).
Time frame: From extubation to discharge from postanesthesia care unit (up to 4 hours)
| Milestone | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion |
|---|---|---|
| Started | 46 | 46 |
| Completed | 46 | 46 |
| Not completed | 0 | 0 |
ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Participants answer 11 questions, each rated on a scale of 1 (Not severe) to 7 (Very severe). Scores were summed for an overall score (range 11 to 77, higher scores indicate more severe dysphagia).
| score on a scale | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion |
|---|---|---|
| Esophageal Symptoms Questionnaire Score (ESQ) | 24 (18 to 31) | 35 (28 to 42) |
ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Participants answer 11 questions, each rated on a scale of 1 (Not severe) to 7 (Very severe). Scores were summed for an overall score (range 11 to 77, higher scores indicate more severe dysphagia).
| score on a scale | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion |
|---|---|---|
| Esophageal Symptoms Questionnaire Score (ESQ) | 16 (14 to 23) | 30 (24 to 35) |
Measured in oral morphine milliequivalents
| morphine milliequivalents (MME) | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion |
|---|---|---|
| Postoperative Opioid Consumption | 0 (0 to 4) | 30 (14 to 41) |
Measured in oral morphine milliequivalents
| morphine milliequivalents (MME) | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion |
|---|---|---|
| Postoperative Day 1 Opioid Consumption | 0 (0 to 0) | 6 (0 to 20) |
Pain measuring scale based on scale from 0 (no pain) to 10 (severe pain).
| score on a scale | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion |
|---|---|---|
| Average Visual Acuity Score Pain Score in Postanesthesia Care Unit | 0 (0 to 3) | 5 (5 to 7) |
Collected over 2 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Age, Categorical(Participants) | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 27 | 54 |
| >=65 years | 19 | 19 | 38 |
| Age, Continuous(years) | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Total |
|---|---|---|---|
| Mean | 59 ± 18 | 58 ± 18 | 58 ± 18 |
| Sex: Female, Male(Participants) | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Total |
|---|---|---|---|
| Female | 27 | 27 | 54 |
| Male | 19 | 19 | 38 |
| Race and Ethnicity Not Collected(Participants) | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Total |
|---|---|---|---|
| United States | 46 | 46 | 92 |
| Body Mass Index (units: kg / m2)(kg/m^2) | Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Total |
|---|---|---|---|
| Mean | 25.6 ± 7.5 | 26.4 ± 7.0 | 26.1 ± 7.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Apr 2023, 27 months.
Results were first posted in May 2024, 1 year 1 month after primary completion.
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Studies of the drug tested here: Magnesium Sulfate