Esophageal Spasm
Conditions
Brief 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.
Interventions
DRUGMagnesium sulfate
Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.
DRUGNormal Saline
Placebo. Bolus and infusion administered similarly under general anesthesia.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Planned peroral endoscopic myotomy procedure
Exclusion criteria
* cannot give consent * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal Symptoms Questionnaire Score (ESQ) | 0 hours postoperatively | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal Symptoms Questionnaire Score (ESQ) | 24 hours postoperatively | 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). |
| Postoperative Opioid Consumption | From extubation to 24 hours after extubation | Measured in oral morphine milliequivalents |
| Postoperative Day 1 Opioid Consumption | From 24 hours after extubation to 48 hours after extubation | Measured in oral morphine milliequivalents |
| Average Visual Acuity Score Pain Score in Postanesthesia Care Unit | From extubation to discharge from postanesthesia care unit (up to 4 hours) | Pain measuring scale based on scale from 0 (no pain) to 10 (severe pain). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| 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. | 46 |
| Total | 92 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 19 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 27 Participants | 54 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 18 | 58 years STANDARD_DEVIATION 18 | 58 years STANDARD_DEVIATION 18 |
| Body Mass Index (units: kg / m2) | 25.6 kg/m^2 STANDARD_DEVIATION 7.5 | 26.4 kg/m^2 STANDARD_DEVIATION 7 | 26.1 kg/m^2 STANDARD_DEVIATION 7.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 46 participants | 46 participants | 92 participants |
| Sex: Female, Male Female | 27 Participants | 27 Participants | 54 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
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).
Time frame: 0 hours postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Esophageal Symptoms Questionnaire Score (ESQ) | 24 score on a scale |
| Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Esophageal Symptoms Questionnaire Score (ESQ) | 35 score on a scale |
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).
Time frame: From extubation to discharge from postanesthesia care unit (up to 4 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Average Visual Acuity Score Pain Score in Postanesthesia Care Unit | 0 score on a scale |
| Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Average Visual Acuity Score Pain Score in Postanesthesia Care Unit | 5 score on a scale |
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).
Time frame: 24 hours postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Esophageal Symptoms Questionnaire Score (ESQ) | 16 score on a scale |
| Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Esophageal Symptoms Questionnaire Score (ESQ) | 30 score on a scale |
Secondary
Postoperative Day 1 Opioid Consumption
Measured in oral morphine milliequivalents
Time frame: From 24 hours after extubation to 48 hours after extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Postoperative Day 1 Opioid Consumption | 0 morphine milliequivalents (MME) |
| Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Postoperative Day 1 Opioid Consumption | 6 morphine milliequivalents (MME) |
Secondary
Postoperative Opioid Consumption
Measured in oral morphine milliequivalents
Time frame: From extubation to 24 hours after extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Postoperative Opioid Consumption | 0 morphine milliequivalents (MME) |
| Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion | Postoperative Opioid Consumption | 30 morphine milliequivalents (MME) |