Magnesium Sulfate Causing Adverse Effects in Therapeutic UseNCT04013243
Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade
A study testing Magnesium Sulfate in people with Magnesium Sulfate Causing Adverse Effects in Therapeutic Use and Neuromuscular Blockade, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
It is well known that magnesium enhances the effect of neuromuscular blocking agents such as rocuronium. However, it is not known how much magnesium can reduce neuromuscular blocking agents in maintaining deep neuromuscular blockade. Read more about this study
- Who is it for?
- Ages 20 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, Neuromuscular Blockade
- What is being tested?
- Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Apr 2019to 30 Jul 2019
- 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who undergo elective robot assisted radical prostatectomy, between 20 and 80 years with a American Society of Anesthesiologists physical status classification of I or II
Who cannot join
- Conduction abnormalities in preoperative EKG such as Atrioventricular block, sinus pause
- Glomerular filtration rate <60ml/min/1.73m2
- Allergy to rocuronium, sugammadex, magnesium
- Medications that interfered with muscle activity
- Neuromuscular disease
- Hypermagnesemia
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Effect of Magnesium on Maintenance Dose of Rocuronium for Deep Neuromuscular Blockade During Robotic Radical Prostatectomy
It is well known that magnesium enhances the effect of neuromuscular blocking agents such as rocuronium. However, it is not known how much magnesium can reduce neuromuscular blocking agents in maintaining deep neuromuscular blockade. Through this study, the investigators will quantitatively analyze the rocuronium saving effect of magnesium.
Read the detailed description
It is well known that magnesium potentiate the effect of neuromuscular blocking agents. It prolonged the duration of rocuronium and reduces the onset time of rocuronium. Magnesium acts on motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, the quantitative rocuronium saving effect of magnesium is not clear. This study's hypothesis is that magnesium would reduce the amount of rocuronium. And the investigators want to evaluate how much magnesium can reduce the amount of rocuronium. Secondary outcome is the effects of magnesium on recovery time, postoperative pain, nausea and vomiting.
- Being tested
- Magnesium Sulfate, Placebo
- Keywords
- Magnesium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
magnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion
PlaceboDrug
Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate group | Active comparator | magnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion Receives: Drug: Magnesium Sulfate |
| Placebo group | Placebo comparator | Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
rocuronium amount
total rocuronium/weight/infusion time
Measured: perioperative - until 48hours
Secondary outcomes (3)
recovery time
time from sugammadex injection to Train-of-four ratio 0.9
Measured: perioperative - until 48hours
postoperative pain
11 point Numerical Rating Scale; 0 (no pain) to 10 (worst imaginable pain), rescue medication
Measured: at postoperative 30minutes, 6hours, 24hours
postoperative nausea and vomiting
Numerical Rating Scale(0-10), rescue medication
Measured: at postoperative 30minutes, 6hours, 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start26 Apr 2019
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Magnesium Sulfate Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiWon Han, Seoul National University Bundang Hospital
- Investigators
- Ah-young Oh, professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013243
- Sponsor's protocol ID
- B-1902/523-007
- Status last verified
- Dec 2020
- First submitted
- 28 Jun 2019
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Queiroz Rangel Micuci AJ, Vercosa N, Filho PAG, de Boer HD, Barbosa DD, Cavalcanti IL. Effect of pretreatment with magnesium sulphate on the duration of intense and deep neuromuscular blockade with rocuronium: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):502-508. doi: 10.1097/EJA.0000000000001003.
PubMed 30985540Han J, Jeon YT, Ryu JH, Koo CH, Nam SW, Cho SI, Oh AY. Effects of magnesium on the dose of rocuronium for deep neuromuscular blockade: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):432-437. doi: 10.1097/EJA.0000000000001329.
PubMed 32890015
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium on Maintenance Dose of Rocuronium for Deep Neuromuscular Blockade During Robotic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04013243
- Acronym / sponsor ID
- B-1902/523-007
- Keywords
- Magnesium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 9 Jul 2019 (actual)
- 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.
It is well known that magnesium enhances the effect of neuromuscular blocking agents such as rocuronium. However, it is not known how much magnesium can reduce neuromuscular blocking agents in maintaining deep neuromuscular blockade. Through this study, the investigators will quantitatively analyze the rocuronium saving effect of magnesium.
Detailed description
It is well known that magnesium potentiate the effect of neuromuscular blocking agents. It prolonged the duration of rocuronium and reduces the onset time of rocuronium. Magnesium acts on motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, the quantitative rocuronium saving effect of magnesium is not clear. This study's hypothesis is that magnesium would reduce the amount of rocuronium. And the investigators want to evaluate how much magnesium can reduce the amount of rocuronium. Secondary outcome is the effects of magnesium on recovery time, postoperative pain, nausea and vomiting.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate group | Active comparator | Drug: Magnesium Sulfatemagnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion |
| Placebo group | Placebo comparator | Drug: PlaceboNormal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergo elective robot assisted radical prostatectomy, between 20 and 80 years with a American Society of Anesthesiologists physical status classification of I or II
Key exclusion criteria (6 listed)
- Conduction abnormalities in preoperative EKG such as Atrioventricular block, sinus pause
- Glomerular filtration rate <60ml/min/1.73m2
- Allergy to rocuronium, sugammadex, magnesium
- Medications that interfered with muscle activity
- Neuromuscular 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 sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion | Drug | Magnesium Sulfate group |
| PlaceboNormal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium. | Drug | Placebo group |
Primary outcome
rocuronium amount
Time frame: perioperative - until 48hours
total rocuronium/weight/infusion time
3 secondary outcomes
recovery time
Time frame: perioperative - until 48hours
postoperative pain
Time frame: at postoperative 30minutes, 6hours, 24hours
postoperative nausea and vomiting
Time frame: at postoperative 30minutes, 6hours, 24hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Results publication: PubMed 30985540Queiroz Rangel Micuci AJ, Vercosa N, Filho PAG, de Boer HD, Barbosa DD, Cavalcanti IL. Effect of pretreatment with magnesium sulphate on the duration of intense and deep neuromuscular blockade with rocuronium: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):502-508. doi: 10.1097/EJA.0000000000001003.
- Derived from this study: PubMed 32890015Han J, Jeon YT, Ryu JH, Koo CH, Nam SW, Cho SI, Oh AY. Effects of magnesium on the dose of rocuronium for deep neuromuscular blockade: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):432-437. doi: 10.1097/EJA.0000000000001329.
- Individual participant dataSharing planned: No
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.
Ah-young Oh, professor principal investigator
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 in people with Magnesium Sulfate Causing Adverse Effects in Therapeutic Use and Neuromuscular Blockade, run by Seoul National University Bundang Hospital 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 1 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: finished, as of the sponsor's last update on 24 Dec 2020. 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. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
rocuronium amount (time frame: perioperative - until 48hours). 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 NCT04013243, which also lists 2 linked publications.
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 24 Dec 2020.