Easy of Laryngoscopy ManipulationNCT01153256
Intubating Condition After Magnesium Pre-treatment
A study testing magnesium sulphate and normal saline in people with Easy of Laryngoscopy Manipulation and Vocal Cord Position or Movement, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Magnesium had an inhibitory effect on neuromuscular transmission and caused a decrease in muscle fiber membrane excitability. It reduces the amount of acetylcholine that is released at the motor nerve terminal by decreasing the calcium conductance of presynaptic voltage-dependent calcium channels. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Easy of Laryngoscopy Manipulation, Vocal Cord Position or Movement, Patient Reaction to Intubation and Cuff Inflation
- What is being tested?
- magnesium sulphate and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Mar 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing operation under general anesthesia
- American Society of Anesthesiologist physical status I or II
- 20-65 year old male or female
Who cannot join
- hepatic or renal dysfunction
- respiratory or cardiovascular dysfunction
- neurologic disorder
- neuromuscular disease
- pregnancy
- body mass index (BMI) >30 kg/m2 or <16.5 kg/m2
Show all 10Show fewer
- anticipated difficult airway
- higher magnesium level than normal range in preoperative evaluation
- chronic medication with calcium channel blocker or magnesium
- history of known allergy to magnesium sulphate or any other study drugs
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: The Influence of Magnesium Sulphate Pretreatment on Intubating Conditions During Rapid Sequence Induction
Magnesium had an inhibitory effect on neuromuscular transmission and caused a decrease in muscle fiber membrane excitability. It reduces the amount of acetylcholine that is released at the motor nerve terminal by decreasing the calcium conductance of presynaptic voltage-dependent calcium channels. After pre-treatment with magnesium, an increased speed of onset and a prolongation of the recovery period of neuromuscular blockade have been observed with other non-depolarizing neuromuscular blocking agent (NMBA) such as atracurium, vecuronium and rocuronium. Rocuronium is the currently preferred NMBA used as an alternative to succinylcholine for rapid tracheal intubation. As an alternative to succinylcholine, high doses of NMBA have been tested for rapid sequence intubation. This excessively high dose of rocuronium, however, prolongs the duration of the neuromuscular block and this may not be warranted in every surgical setting.
The reduction of onset time of rocuronium by magnesium pre-treatment can make intubation condition more rapid and much better clinically. It will thus be interesting to compare intubation conditions of a standard intubation dose of rocuronium after magnesium pre-treatment with high dose of rocuronium or standard dose of rocuronium.
- Conditions
- Easy of Laryngoscopy Manipulation, Vocal Cord Position or Movement, Patient Reaction to Intubation and Cuff Inflation, Mean Arterial Pressure, Heart Rate
- Being tested
- magnesium sulphate, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium sulphateDrug
The patients of group M receive 50 mg/kg of magnesium sulphate in 100 ml of isotonic saline over 10 min immediately before anaesthesia induction. After induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg), rocuronium 0.6 mg/kg is given over 5 s in a running infusion.
normal salineDrug
Patients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.6 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg).
normal salineDrug
Patients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.9 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| group M | Experimental | Not described Receives: Drug: magnesium sulphate |
| Group R-0.6 | Placebo comparator | Not described Receives: Drug: normal saline |
| Group R-0.9 | Placebo comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the intubating conditions
The anesthesiologist also assessed the intubating conditions as per the intubation scoring system of the Good Clinical Research Practice guideline.
Measured: 1 minute during intervention
Secondary outcomes (2)
mean arterial pressure (MAP)
They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min.
Measured: 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min.
heart rate (HR)
They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min.
Measured: 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Easy of Laryngoscopy ManipulationStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153256
- Sponsor's protocol ID
- Mg_rocu
- Status last verified
- Jan 2012
- First submitted
- 9 Apr 2010
- Last updated
- 9 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Magnesium Sulphate Pretreatment on Intubating Conditions During Rapid Sequence Induction
- ClinicalTrials.gov ID
- NCT01153256
- Acronym / sponsor ID
- Mg_rocu
- Conditions
- Easy of Laryngoscopy Manipulation, Vocal Cord Position or Movement, Patient Reaction to Intubation and Cuff Inflation, Mean Arterial Pressure, Heart Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Jun 2010 (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.
Magnesium had an inhibitory effect on neuromuscular transmission and caused a decrease in muscle fiber membrane excitability. It reduces the amount of acetylcholine that is released at the motor nerve terminal by decreasing the calcium conductance of presynaptic voltage-dependent calcium channels. After pre-treatment with magnesium, an increased speed of onset and a prolongation of the recovery period of neuromuscular blockade have been observed with other non-depolarizing neuromuscular blocking agent (NMBA) such as atracurium, vecuronium and rocuronium. Rocuronium is the currently preferred NMBA used as an alternative to succinylcholine for rapid tracheal intubation. As an alternative to succinylcholine, high doses of NMBA have been tested for rapid sequence intubation. This excessively high dose of rocuronium, however, prolongs the duration of the neuromuscular block and this may not be warranted in every surgical setting.
The reduction of onset time of rocuronium by magnesium pre-treatment can make intubation condition more rapid and much better clinically. It will thus be interesting to compare intubation conditions of a standard intubation dose of rocuronium after magnesium pre-treatment with high dose of rocuronium or standard dose of rocuronium.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group M | Experimental | Drug: magnesium sulphate |
| Group R-0.6 | Placebo comparator | Drug: normal saline |
| Group R-0.9 | Placebo comparator | Drug: normal saline |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing operation under general anesthesia
- American Society of Anesthesiologist physical status I or II
- 20-65 year old male or female
Key exclusion criteria (10 listed)
- hepatic or renal dysfunction
- respiratory or cardiovascular dysfunction
- neurologic disorder
- neuromuscular disease
- pregnancy
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 sulphateThe patients of group M receive 50 mg/kg of magnesium sulphate in 100 ml of isotonic saline over 10 min immediately before anaesthesia induction. After induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg), rocuronium 0.6 mg/kg is given over 5 s in a running infusion. | Drug | group M |
| normal salinePatients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.6 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg). | Drug | Group R-0.6 |
| normal salinePatients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.9 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg). | Drug | Group R-0.9 |
Primary outcome
the intubating conditions
Time frame: 1 minute during intervention
The anesthesiologist also assessed the intubating conditions as per the intubation scoring system of the Good Clinical Research Practice guideline.
2 secondary outcomes
mean arterial pressure (MAP)
Time frame: 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min.
heart rate (HR)
Time frame: 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min.
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 9 Jan 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 sulphate and normal saline in people with Easy of Laryngoscopy Manipulation and Vocal Cord Position or Movement, 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 10 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 9 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. 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?
the intubating conditions (time frame: 1 minute during intervention). 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 9 Jan 2012.