Neuromuscular BlockadeNCT03020706
Effect of Magnesium Sulphate on Neostigmine
A study testing Magnesium Sulfate, Injectable in people with Neuromuscular Blockade, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of magnesium sulphate on neostigmine-induced reversal of neuromuscular block by rocuronium Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Magnesium Sulfate, Injectable
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA status 1 or 2
- patients undergoing surgery for more than 60 min under general anesthesia
Who cannot join
- electrolyte abnormalities
- medication on aminoglycoside, antiepileptic drug, magnesium
- underweight or obesity (BMI <18.5 or >30)
- renal insufficiency (Cr>1.4 mg/dl)
- AV block
- neuromuscular disease (ex: Myathenia gravis)
Trial locations and contacts
1 site in 1 country.
Sang-Hwan Do, MD, Ph D contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyungi-do
Hee-Yeon Park, MD, +82 10 3360 0790, hypark@gilhospital.com
About this study
Official title: Effect of Magnesium Sulphate on Neostigmine-induced Reversal of Neuromuscular Block by Rocuronium
The purpose of this study is to evaluate the effect of magnesium sulphate on neostigmine-induced reversal of neuromuscular block by rocuronium
Read the detailed description
Comparison of reversa time by neostigmine in magnesium group and control group
- Conditions
- Neuromuscular Blockade
- Being tested
- Magnesium Sulfate, Injectable
- Keywords
- magnesium sulphate, neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate, InjectableDrug
Also called magnesium sulphate
magnesium sulphate intravenous administration during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Experimental | magnesium sulfate, injectable intravenous administration (50mg/kg diluted in 100ml normal saline) during general anesthesia Receives: Drug: Magnesium Sulfate, Injectable |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
reversal time
reversal time: from neostigmine injection to TOF ratio 0.9
Measured: through study completion, an average of 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionJan 2017
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital
- Responsible party
- Principal investigator, Park Hee-Yeon, Gachon University Gil Medical Center
- Investigators
- Sang-Hwan Do, MD, Ph D, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020706
- Sponsor's protocol ID
- B-1610/367-002
- Status last verified
- Jan 2017
- First submitted
- 8 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulphate on Neostigmine-induced Reversal of Neuromuscular Block by Rocuronium
- ClinicalTrials.gov ID
- NCT03020706
- Acronym / sponsor ID
- B-1610/367-002
- Conditions
- Neuromuscular Blockade
- Keywords
- magnesium sulphate, neostigmine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Hospital
- Study start
- Dec 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of magnesium sulphate on neostigmine-induced reversal of neuromuscular block by rocuronium
Detailed description
Comparison of reversa time by neostigmine in magnesium group and control group
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Experimental | Drug: Magnesium Sulfate, Injectablemagnesium sulfate, injectable intravenous administration (50mg/kg diluted in 100ml normal saline) during general anesthesia |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA status 1 or 2
- patients undergoing surgery for more than 60 min under general anesthesia
Key exclusion criteria (6 listed)
- electrolyte abnormalities
- medication on aminoglycoside, antiepileptic drug, magnesium
- underweight or obesity (BMI <18.5 or >30)
- renal insufficiency (Cr>1.4 mg/dl)
- AV block
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 Sulfate, InjectableAlso: magnesium sulphatemagnesium sulphate intravenous administration during general anesthesia | Drug | Magnesium |
Primary outcome
reversal time
Time frame: through study completion, an average of 90 minutes
reversal time: from neostigmine injection to TOF ratio 0.9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Neuromuscular Blockade
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
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.
Sang-Hwan Do, MD, Ph D contact
Sang-Hwan Do, MD, Ph D study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate, Injectable in people with Neuromuscular Blockade, run by Gachon University Gil Medical Center at 1 site in South Korea.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Jan 2017. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee-Yeon Park, MD (+82 10 3360 0790, hypark@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reversal time (time frame: through study completion, an average of 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2017.