Observation of Neuromuscular BlockNCT02100293
Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium
A study testing magnesium sulfate 30 mg/kg and saline in people with Observation of Neuromuscular Block and Intubation Condition, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Observation of Neuromuscular Block, Intubation Condition, Surgical Condition
- What is being tested?
- magnesium sulfate 30 mg/kg and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Dec 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 yr American Society of Anesthesiologists physical status 1 or 2, BMI of 20-24.9 kg/m2 scheduled for elective laryngeal microsurgery
Who cannot join
- severe respiratory or cardiac disease hepatic or renal function impairment neuromuscular disease on medications affecting neuromuscular function with known allergy to the drugs
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Univ. Bundang Hospita
Seongnam-si, Gyeonggi-do, 463-707
About this study
This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition.
- Being tested
- magnesium sulfate 30 mg/kg, saline
- Keywords
- magnesium sulfate, rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium sulfate 30 mg/kgDrug
Patients in each group received the magnesium sulfate 30 mg/kg for 2 min in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia
salineDrug
Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| standard dose rocuronium group | Active comparator | pretreatment of saline 100ml and rocuronium 0.6 mg/kg Receives: Drug: saline |
| low dose rocuronium group | Active comparator | pretreatment of saline 100ml and rocuronium 0.45 mg/kg Receives: Drug: saline |
| low dose rocuronium plus magnesium group | Active comparator | pretreatment of magnesium sulfate 30 mg/kg and rocuronium 0.45 mg/kg Receives: Drug: magnesium sulfate 30 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset time of rocuronium
from injection of rocuronium to T1 suppression more than 95% up to 10 minutes
Measured: from injection of rocuronium to T1 suppression more than 95% up to 10 minutes
Secondary outcomes (1)
maximal suppression time and duration of rocuronium
Measured: time from the injection of rocuronium to T1 maximal suppression time and reversal of T1 25% up to 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Observation of Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang Hwan Do, Principal investigator, Seoul National Univ. Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100293
- Sponsor's protocol ID
- B-1307/209-006
- Status last verified
- Jul 2015
- First submitted
- 11 Dec 2013
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium
- ClinicalTrials.gov ID
- NCT02100293
- Acronym / sponsor ID
- B-1307/209-006
- Keywords
- magnesium sulfate, rocuronium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Mar 2014 (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.
This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard dose rocuronium group | Active comparator | Drug: salinepretreatment of saline 100ml and rocuronium 0.6 mg/kg |
| low dose rocuronium group | Active comparator | Drug: salinepretreatment of saline 100ml and rocuronium 0.45 mg/kg |
| low dose rocuronium plus magnesium group | Active comparator | Drug: magnesium sulfate 30 mg/kgpretreatment of magnesium sulfate 30 mg/kg and rocuronium 0.45 mg/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-75 yr American Society of Anesthesiologists physical status 1 or 2, BMI of 20-24.9 kg/m2 scheduled for elective laryngeal microsurgery
Key exclusion criteria (1 listed)
- severe respiratory or cardiac disease hepatic or renal function impairment neuromuscular disease on medications affecting neuromuscular function with known allergy to the drugs
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 30 mg/kgPatients in each group received the magnesium sulfate 30 mg/kg for 2 min in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia | Drug | low dose rocuronium plus magnesium group |
| salinePatients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia | Drug | low dose rocuronium group, standard dose rocuronium group |
Primary outcome
onset time of rocuronium
Time frame: from injection of rocuronium to T1 suppression more than 95% up to 10 minutes
from injection of rocuronium to T1 suppression more than 95% up to 10 minutes
1 secondary outcome
maximal suppression time and duration of rocuronium
Time frame: time from the injection of rocuronium to T1 maximal suppression time and reversal of T1 25% up to 1 hours
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 18 Apr 2016.
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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.
Sang Hwan Do principal investigator
Seoul National Univ. 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 30 mg/kg and saline in people with Observation of Neuromuscular Block and Intubation Condition, run by Seoul National University 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 1 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 18 Apr 2016. 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?
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?
onset time of rocuronium (time frame: from injection of rocuronium to T1 suppression more than 95% up to 10 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 18 Apr 2016.