Muscle RelaxationNCT01389791
MgSO4 Combined With Rocuronium Priming
A study testing magnesium sulfate, priming and magnesium sulfate and priming in people with Muscle Relaxation, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Priming with either rocuronium or MgSO4 is known to accelerate the effect of rocuronium on muscle relaxation. The purpose of this study is to define the effect of MgSO4 on the rocuronium-priming. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Relaxation
- What is being tested?
- magnesium sulfate, priming and magnesium sulfate and priming
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Jan 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of ASA Ⅰ-Ⅱ
- aged 18~65
- scheduled to undergo elective surgery under general anesthesia
Who cannot join
- risk of pulmonary aspiration
- anticipated airway difficulty
- reactive airway disease
- allergic to study drugs
- neuromuscular / cardiovascular/ renal/ hepatic disease
- atrioventricular conduction disturbance
Show all 9Show fewer
- BMI < 18.5 or > 24.9
- chronic treatment with calcium channel blocker
- medications which affect muscle relaxation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university Bundang hospital
Seongnam, Kyoung-ki-do, 463-707
About this study
Priming with either rocuronium or MgSO4 is known to accelerate the effect of rocuronium on muscle relaxation. The purpose of this study is to define the effect of MgSO4 on the rocuronium-priming.
Read the detailed description
Acceleration of muscle relaxation is beneficial in rapid-sequence intubation. If MgSO4 combined with priming is efficient in accelerating muscle relaxation, it would be an interesting alternative to rapid-sequence intubation.
- Conditions
- Muscle Relaxation
- Being tested
- magnesium sulfate, priming, magnesium sulfate and priming
- Keywords
- muscle relaxation, magnesium sulfate, rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium sulfateDrug
Also called MgSO4
Patients in this group receive intravenous MgSO4 50mg/kg before administration of rocuronium (induction dose).
primingDrug
Also called rocuronium-priming
Patients in this group receive 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.
magnesium sulfate and primingDrug
Also called MgSO4 & priming
Patients in this group receive MgSO4 50mg/kg and 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.
| Study group | Role | What they receive |
|---|---|---|
| Roc | No intervention | Patients in this group receive neither MgSO4 nor priming dose of rocuronium. |
| priming | Active comparator | patients in this group receive 0.06mg/kg of rocuronium before 0.54mg/kg of rocuronium. Receives: Drug: priming |
| Mg&priming | Experimental | Patients in this group receive MgSO4 50mg/kg and 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium. Receives: Drug: magnesium sulfate and priming |
| MgSO4 | Active comparator | Patients in this group receive intravenous MgSO4 before administration of rocuronium. Receives: Drug: magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
time from injection of induction dose of rocuronium until 95% depression of TOF
Measured: time from injection of induction dose of rocuronium until 95% depression of TOF, upto 5 min
Secondary outcomes (2)
rocuronium duration
time from injection of induction dose of rocuronium until train-of-four count reaches two.
Measured: time from injection of induction dose of rocuronium until train-of-four count reaches two.
intubating condition
rapid sesequence intubation condition is evaluated.
Measured: time from injection of induction dose of rocuronium until tracheal intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Mihyun, Seoul National University Bundang Hospital
- Investigators
- Sanghwan Do, M.D., PH.D., Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389791
- Sponsor's protocol ID
- Mg priming
- Status last verified
- Jan 2012
- First submitted
- 26 May 2011
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MgSO4 Combined With Rocuronium Priming
- ClinicalTrials.gov ID
- NCT01389791
- Acronym / sponsor ID
- Mg priming
- Conditions
- Muscle Relaxation
- Keywords
- muscle relaxation, magnesium sulfate, rocuronium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 8 Jul 2011 (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.
Priming with either rocuronium or MgSO4 is known to accelerate the effect of rocuronium on muscle relaxation. The purpose of this study is to define the effect of MgSO4 on the rocuronium-priming.
Detailed description
Acceleration of muscle relaxation is beneficial in rapid-sequence intubation. If MgSO4 combined with priming is efficient in accelerating muscle relaxation, it would be an interesting alternative to rapid-sequence intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Roc | No intervention | –Patients in this group receive neither MgSO4 nor priming dose of rocuronium. |
| priming | Active comparator | Drug: primingpatients in this group receive 0.06mg/kg of rocuronium before 0.54mg/kg of rocuronium. |
| Mg&priming | Experimental | Drug: magnesium sulfate and primingPatients in this group receive MgSO4 50mg/kg and 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium. |
| MgSO4 | Active comparator | Drug: magnesium sulfatePatients in this group receive intravenous MgSO4 before administration of rocuronium. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients of ASA Ⅰ-Ⅱ
- aged 18~65
- scheduled to undergo elective surgery under general anesthesia
Key exclusion criteria (9 listed)
- risk of pulmonary aspiration
- anticipated airway difficulty
- reactive airway disease
- allergic to study drugs
- neuromuscular / cardiovascular/ renal/ hepatic 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 sulfateAlso: MgSO4Patients in this group receive intravenous MgSO4 50mg/kg before administration of rocuronium (induction dose). | Drug | MgSO4 |
| primingAlso: rocuronium-primingPatients in this group receive 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium. | Drug | priming |
| magnesium sulfate and primingAlso: MgSO4 & primingPatients in this group receive MgSO4 50mg/kg and 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium. | Drug | Mg&priming |
Primary outcome
time from injection of induction dose of rocuronium until 95% depression of TOF
Time frame: time from injection of induction dose of rocuronium until 95% depression of TOF, upto 5 min
2 secondary outcomes
rocuronium duration
Time frame: time from injection of induction dose of rocuronium until train-of-four count reaches two.
intubating condition
Time frame: time from injection of induction dose of rocuronium until tracheal intubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2012.
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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.
Sanghwan Do, M.D., 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, priming and magnesium sulfate and priming in people with Muscle Relaxation, 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 3 inclusion and 9 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 10 Jan 2012. 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 Mihyun Kim, MD (82-31-787-2034, snmd56@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time from injection of induction dose of rocuronium until 95% depression of TOF (time frame: time from injection of induction dose of rocuronium until 95% depression of TOF, upto 5 min). 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 10 Jan 2012.