Esophageal SpasmPhase 2MgPOEMNCT04638881

Magnesium for Peroral Endoscopic Myotomy

A Phase 2 study testing Magnesium sulfate and Normal Saline in people with Esophageal Spasm, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Esophageal Spasm
What is being tested?: Magnesium sulfate and Normal Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 92 participants
Where: 1 siteUnited States
Study dates: 28 Dec 2020to 13 Apr 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Planned peroral endoscopic myotomy procedure

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford Health Care
Stanford, California, 94305

Other trials in United States

About this study

Official title: A Prospective, Randomized, Double-blind, Placebo-controlled Trial of the Effects of Magnesium Sulfate on Postoperative Esophageal Spasm-associated Pain Following Peroral Endoscopic Myotomy

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.

Conditions: Esophageal Spasm
Being tested: Magnesium sulfate, Normal Saline
Medical subject headings: Esophageal Spasm, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnesium sulfateDrug
Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.
Normal SalineDrug
Placebo. Bolus and infusion administered similarly under general anesthesia.

Study groups in NCT04638881
Study group	Role	What they receive
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. Receives: Drug: Magnesium sulfate
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. Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 0 hours postoperatively

Secondary outcomes (4)

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).
Measured: 24 hours postoperatively
Postoperative Opioid Consumption
Measured in oral morphine milliequivalents
Measured: From extubation to 24 hours after extubation
Postoperative Day 1 Opioid Consumption
Measured in oral morphine milliequivalents
Measured: 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).
Measured: From extubation to discharge from postanesthesia care unit (up to 4 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Dec 202013 Apr 2023

First posted20 Nov 2020
Study start28 Dec 2020
Primary completion13 Apr 2023
Study completion13 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Esophageal SpasmStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04638881
Sponsor's protocol ID: 58859
Acronym: MgPOEM
Status last verified: Apr 2024
First submitted: 16 Nov 2020
Last updated: 21 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features
Recruiting
Swallowing Rehabilitation Program for Head and Neck Tumor Patients
Head and Neck Cancer (H&N)
RecruitingPhase 2/3
Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy
Esophageal Cancer Surgery, Esophagectomy
RecruitingObservational study
Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
Achalasia, Esophageal Spasm, Diffuse
Recruiting
Dumping Syndrome and Esophageal Atresia
Oesophageal Atresia, Dumping Syndrome

All Esophageal Spasm trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Double-blind, Placebo-controlled Trial of the Effects of Magnesium Sulfate on Postoperative Esophageal Spasm-associated Pain Following Peroral Endoscopic Myotomy
ClinicalTrials.gov ID: NCT04638881
Acronym / sponsor ID: MgPOEM / 58859
Conditions: Esophageal Spasm
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 28 Dec 2020 (actual)
Primary completion: 13 Apr 2023 (actual)
Study completion: 13 Apr 2023 (actual)
First posted: 20 Nov 2020 (actual)
Results: Posted 21 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Magnesium sulfate 50 mg/kg bolus + 25 mg/kg/hr infusion	Experimental	Drug: Magnesium sulfateBolus 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	Drug: Normal SalineBolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Planned peroral endoscopic myotomy procedure

Key exclusion criteria (8 listed)

cannot give consent
patients who are clinically unstable and/or require urgent/emergent intervention
previous esophageal myotomy
preexisting hypermagnesemia
end-stage renal disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Magnesium sulfateMagnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.	Drug	Magnesium sulfate 50 mg/kg bolus + 25 mg/kg/hr infusion
Normal SalinePlacebo. Bolus and infusion administered similarly under general anesthesia.	Drug	Normal saline 0.9% 50 mg/kg bolus + 25 mg/kg/hr infusion

Primary outcome

Esophageal Symptoms Questionnaire Score (ESQ)
Time frame: 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).

4 secondary outcomes

Esophageal Symptoms Questionnaire Score (ESQ)
Time frame: 24 hours postoperatively
Postoperative Opioid Consumption
Time frame: From extubation to 24 hours after extubation
Postoperative Day 1 Opioid Consumption
Time frame: From 24 hours after extubation to 48 hours after extubation
Average Visual Acuity Score Pain Score in Postanesthesia Care Unit
Time frame: From extubation to discharge from postanesthesia care unit (up to 4 hours)

Results and safety

Results posted to the registry on 21 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion	46	46
Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion	46	46

Primary outcome: Esophageal Symptoms Questionnaire Score (ESQ)

Time frame: 0 hours postoperatively. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion n = 46	Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion n = 46
Value	24 (18 to 31)	35 (28 to 42)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion	0 of 46 (0%)	0 of 46 (0%)	0 of 46
Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion	0 of 46 (0%)	0 of 46 (0%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Esophageal Spasm

RecruitingObservational study
PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features
Recruiting
Swallowing Rehabilitation Program for Head and Neck Tumor Patients
Head and Neck Cancer (H&N)
RecruitingPhase 2/3
Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy
Esophageal Cancer Surgery, Esophagectomy
RecruitingObservational study
Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
Achalasia, Esophageal Spasm, Diffuse
Recruiting
Dumping Syndrome and Esophageal Atresia
Oesophageal Atresia, Dumping Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard K Kim, MD principal investigator

Stanford University

Joo H Hwang, MD PhD principal investigator

Stanford University

Ban C Tsui, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Magnesium sulfate and Normal Saline in people with Esophageal Spasm, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Esophageal Symptoms Questionnaire Score (ESQ) (time frame: 0 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04638881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.