Intubating ConditionNCT01479751
Comparison of Methods to Facilitate Rapid Sequence Intubation
A study testing Magnesium Sulfate, Ketamine and rocuronium in people with Intubating Condition, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In this study, methods which are known for facilitating rapid sequence intubation or accelerating rocuronium (Roc)onset are compared including magnesium (Mg), ketamine pretreatment, large dose rocuronium and priming. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubating Condition
- What is being tested?
- Magnesium Sulfate, Ketamine and rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Aug 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
- age 18 - 65 years,
- ASA 1 - 2,
- patients scheduled for elective surgery under general anesthesia,
- BMI 18.5-24.9 kg/m2
- Mallampati class I-II
Who cannot join
- neuromuscular disorder,
- cardiac/hepatic/renal insufficiency,
- pregnant.
- anticipated difficult airway
- medications that influence neuromuscular transmission
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang hopital
Seongnam-si, Gyeonggi-do, 464-707
About this study
Official title: Comparison of Mg, Ketamine, Large Dose Rocuronium, and Priming on Intubating Condition in Rapid Sequence Intubation
In this study, methods which are known for facilitating rapid sequence intubation or accelerating rocuronium (Roc)onset are compared including magnesium (Mg), ketamine pretreatment, large dose rocuronium and priming.
Read the detailed description
Patients are pretreated with Mg, ketamine, or priming dose Roc. Two groups do not receive pretreatment, but are given Roc 0.6 mg/kg or 0.9 mg/kg.
- Conditions
- Intubating Condition
- Being tested
- Magnesium Sulfate, Ketamine, rocuronium
- Keywords
- Rocuronium, magnesium, priming, ketamine, intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Patients receive MgSO4 50 mg/kg for 10 min before injection of Roc 0.6 mg/kg.
KetamineDrug
patients receive ketamine 0.5 mg/kg 2 min before Roc injection.
rocuroniumDrug
Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| ketamine | Experimental | Patients receive ketamine 0.5 mg/kg 2 min before Roc injection. Receives: Drug: Ketamine |
| priming | Experimental | Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg. Receives: Drug: rocuronium |
| Roc 0.9 | No intervention | Patients receive Roc 0.9 mg/kg as an induction dose. |
| Control | No intervention | Patients receive Roc 0.6 mg/kg without any pretreatments of Mg, ketamine, or priming. |
| Mg | Experimental | Patients receive magnesium sulfate (MgSO4) 50 mg/kg over 10 min before Roc injection. Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation score
Patients are tracheally intubated, and intubation scores(poor, good,excellent)are rated.
Measured: participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.
Secondary outcomes (4)
Roc duration
Time from the start of rocuronium injection until reappearance of two muscle twitches in TOF stimulations is measured, using ToF-Watch sx.
Measured: participants will be followed when TOF count reaches two, an expected average of 40 min.
Roc onset
Time from the start of rocuronium injection until TOF count=0 using TOF-Watch sx.
Measured: participants will be followed when TOFcount =0 within an expected average of 4 min from the start of rocuronium injection.
Hemodynamic variables
Mean arterial pressure (MAP)and heart rate (HR) are measured at baseline, before intubation, and 1, 2, 3, 4, 5 min after intubation.
Measured: participants will be followed at baseline, before and for 5 min after the intubation, an expected average of 8 min after the start of anesthetic induction.
TOF% at intubation
neumeric value expressed as %, displayed on the monitor of TOF watch-Sx in TOF stimulation (ex. 5% on the display means 95% suppression of T1)
Measured: participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubating ConditionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
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
- Mihyun Kim, doctor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479751
- Sponsor's protocol ID
- facilitating RSI
- Status last verified
- Aug 2012
- First submitted
- 22 Nov 2011
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mg, Ketamine, Large Dose Rocuronium, and Priming on Intubating Condition in Rapid Sequence Intubation
- ClinicalTrials.gov ID
- NCT01479751
- Acronym / sponsor ID
- facilitating RSI
- Conditions
- Intubating Condition
- Keywords
- Rocuronium, magnesium, priming, ketamine, intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Nov 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.
In this study, methods which are known for facilitating rapid sequence intubation or accelerating rocuronium (Roc)onset are compared including magnesium (Mg), ketamine pretreatment, large dose rocuronium and priming.
Detailed description
Patients are pretreated with Mg, ketamine, or priming dose Roc. Two groups do not receive pretreatment, but are given Roc 0.6 mg/kg or 0.9 mg/kg.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ketamine | Experimental | Drug: KetaminePatients receive ketamine 0.5 mg/kg 2 min before Roc injection. |
| priming | Experimental | Drug: rocuroniumPatients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg. |
| Roc 0.9 | No intervention | –Patients receive Roc 0.9 mg/kg as an induction dose. |
| Control | No intervention | –Patients receive Roc 0.6 mg/kg without any pretreatments of Mg, ketamine, or priming. |
| Mg | Experimental | Drug: Magnesium SulfatePatients receive magnesium sulfate (MgSO4) 50 mg/kg over 10 min before Roc injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 - 65 years,
- ASA 1 - 2,
- patients scheduled for elective surgery under general anesthesia,
- BMI 18.5-24.9 kg/m2
- Mallampati class I-II
Key exclusion criteria (5 listed)
- neuromuscular disorder,
- cardiac/hepatic/renal insufficiency,
- pregnant.
- anticipated difficult airway
- medications that influence neuromuscular transmission
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 SulfatePatients receive MgSO4 50 mg/kg for 10 min before injection of Roc 0.6 mg/kg. | Drug | Mg |
| Ketaminepatients receive ketamine 0.5 mg/kg 2 min before Roc injection. | Drug | ketamine |
| rocuroniumPatients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg. | Drug | priming |
Primary outcome
Intubation score
Time frame: participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.
Patients are tracheally intubated, and intubation scores(poor, good,excellent)are rated.
4 secondary outcomes
Roc duration
Time frame: participants will be followed when TOF count reaches two, an expected average of 40 min.
Roc onset
Time frame: participants will be followed when TOFcount =0 within an expected average of 4 min from the start of rocuronium injection.
Hemodynamic variables
Time frame: participants will be followed at baseline, before and for 5 min after the intubation, an expected average of 8 min after the start of anesthetic induction.
TOF% at intubation
Time frame: participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.
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 27 Aug 2012.
Related trials for Intubating Condition
Enrolling by invitation
A Study Of T1/Tref Intubating Conditions
Intubation
Not yet recruiting
Air-Q in Totally Edentulous and Dentate Geriatric Patients
Postoperative Complications, Sore-throat
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.
Mihyun Kim, doctor 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, Ketamine and rocuronium in people with Intubating Condition, 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 5 inclusion and 5 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 27 Aug 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?
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?
Intubation score (time frame: participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.). 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 27 Aug 2012.