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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium sulfate 50 mg/kg bolus + 25 mg/kg/hr infusion | Experimental | Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation. |
|
| Normal saline 0.9% 50 mg/kg bolus + 25 mg/kg/hr infusion | Placebo Comparator | Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulfate | Drug | Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 0 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours postoperatively |
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Inclusion Criteria:
- Planned peroral endoscopic myotomy procedure
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard K Kim, MD | Stanford University | Principal Investigator |
| Joo H Hwang, MD PhD | Stanford University | Principal Investigator |
| Ban C Tsui, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 0 hours postoperatively |
|
2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard K. Kim | Stanford University School of Medicine | 3475869661 | rkwkim@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2020 | Mar 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015155 | Esophageal Spasm, Diffuse |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Normal Saline | Drug | Placebo. Bolus and infusion administered similarly under general anesthesia. |
|
| Postoperative Opioid Consumption | Measured in oral morphine milliequivalents | From extubation to 24 hours after extubation |
| Postoperative Day 1 Opioid Consumption | Measured in oral morphine milliequivalents | 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). | From extubation to discharge from postanesthesia care unit (up to 4 hours) |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (units: kg / m2) | Mean | Standard Deviation | kg/m^2 |
|
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. |
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours postoperatively |
|
|
|
| Secondary | Postoperative Opioid Consumption | Measured in oral morphine milliequivalents | Posted | Median | Inter-Quartile Range | morphine milliequivalents (MME) | From extubation to 24 hours after extubation |
|
|
|
| Secondary | Postoperative Day 1 Opioid Consumption | Measured in oral morphine milliequivalents | Posted | Median | Inter-Quartile Range | morphine milliequivalents (MME) | From 24 hours after extubation to 48 hours after extubation |
|
|
|
| Secondary | Average Visual Acuity Score Pain Score in Postanesthesia Care Unit | Pain measuring scale based on scale from 0 (no pain) to 10 (severe pain). | Posted | Median | Inter-Quartile Range | score on a scale | From extubation to discharge from postanesthesia care unit (up to 4 hours) |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | 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. | 0 | 46 | 0 | 46 | 0 | 46 |
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| D004066 | Digestive System Diseases |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |