Trial Outcomes & Findings for Magnesium for Peroral Endoscopic Myotomy (NCT NCT04638881)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

92 participants

Primary outcome timeframe

0 hours postoperatively

Results posted on

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	46	46
Overall Study COMPLETED	46	46
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion n=46 Participants 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 n=46 Participants 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.	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=46 Participants	0 Participants n=46 Participants	0 Participants n=92 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=46 Participants	27 Participants n=46 Participants	54 Participants n=92 Participants
Age, Categorical >=65 years	19 Participants n=46 Participants	19 Participants n=46 Participants	38 Participants n=92 Participants
Age, Continuous	59 years STANDARD_DEVIATION 18 • n=46 Participants	58 years STANDARD_DEVIATION 18 • n=46 Participants	58 years STANDARD_DEVIATION 18 • n=92 Participants
Sex: Female, Male Female	27 Participants n=46 Participants	27 Participants n=46 Participants	54 Participants n=92 Participants
Sex: Female, Male Male	19 Participants n=46 Participants	19 Participants n=46 Participants	38 Participants n=92 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	46 participants n=46 Participants	46 participants n=46 Participants	92 participants n=92 Participants
Body Mass Index (units: kg / m2)	25.6 kg/m^2 STANDARD_DEVIATION 7.5 • n=46 Participants	26.4 kg/m^2 STANDARD_DEVIATION 7.0 • n=46 Participants	26.1 kg/m^2 STANDARD_DEVIATION 7.2 • n=92 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion n=46 Participants 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 n=46 Participants 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.
Esophageal Symptoms Questionnaire Score (ESQ)	24 score on a scale Interval 18.0 to 31.0	35 score on a scale Interval 28.0 to 42.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion n=46 Participants 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 n=46 Participants 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.
Esophageal Symptoms Questionnaire Score (ESQ)	16 score on a scale Interval 14.0 to 23.0	30 score on a scale Interval 24.0 to 35.0

SECONDARY outcome

Timeframe: From extubation to 24 hours after extubation

Measured in oral morphine milliequivalents

Outcome measures

Outcome measures
Measure	Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion n=46 Participants 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 n=46 Participants 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.
Postoperative Opioid Consumption	0 morphine milliequivalents (MME) Interval 0.0 to 4.0	30 morphine milliequivalents (MME) Interval 14.0 to 41.0

SECONDARY outcome

Timeframe: From 24 hours after extubation to 48 hours after extubation

Measured in oral morphine milliequivalents

Outcome measures

Outcome measures
Measure	Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion n=46 Participants 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 n=46 Participants 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.
Postoperative Day 1 Opioid Consumption	0 morphine milliequivalents (MME) Interval 0.0 to 0.0	6 morphine milliequivalents (MME) Interval 0.0 to 20.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion n=46 Participants 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 n=46 Participants 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.
Average Visual Acuity Score Pain Score in Postanesthesia Care Unit	0 score on a scale Interval 0.0 to 3.0	5 score on a scale Interval 5.0 to 7.0

Adverse Events

Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard K. Kim

Stanford University School of Medicine

Phone: 3475869661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place