IntubationNCT00783731
Low Dose of Midazolam is Superior to Conventional Dose for Rapid Sequence Intubation in Emergency Department (ED)
A study testing Low dose midazolam in people with Intubation, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Midazolam has been used in rapid sequence intubation for a long time, and the recommended dose is 0.1mg/kg. In some studies, however, the reduced dose has been used with the concern of hemodynamic instability. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation
- What is being tested?
- Low dose midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 2 sitesSouth Korea
- Study dates
- Oct 2008to Jan 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who need rapid sequence intubation in emergency room
Who cannot join
- in hypotension(systolic blood pressure less than 90 mmHg
- severe trauma patients
- pregnant
- allergic to midazolam, etomidate
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital, Emergency room
Seongnam-si, Gyeonggi-do, 463-707
Boramae Medical Center
Seoul, 156-707
About this study
Midazolam has been used in rapid sequence intubation for a long time, and the recommended dose is 0.1mg/kg. In some studies, however, the reduced dose has been used with the concern of hemodynamic instability. We would like to investigate that the low dose midazolam could be used rather than the standard recommended dose, and also compare it to the etomidate, recently used sedatives, with respect to the side effects and the easy performance of intubation.
- Conditions
- Intubation
- Being tested
- Low dose midazolam
- Keywords
- intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose midazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose midazolam | Experimental | Not described Receives: Drug: Low dose midazolam |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783731
- Sponsor's protocol ID
- RSI study
- Status last verified
- Jul 2011
- First submitted
- 30 Oct 2008
- Last updated
- 26 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose of Midazolam is Superior to Conventional Dose for Rapid Sequence Intubation in Emergency Department (ED)
- ClinicalTrials.gov ID
- NCT00783731
- Acronym / sponsor ID
- RSI study
- Conditions
- Intubation
- Keywords
- intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Nov 2008 (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.
Midazolam has been used in rapid sequence intubation for a long time, and the recommended dose is 0.1mg/kg. In some studies, however, the reduced dose has been used with the concern of hemodynamic instability. We would like to investigate that the low dose midazolam could be used rather than the standard recommended dose, and also compare it to the etomidate, recently used sedatives, with respect to the side effects and the easy performance of intubation.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low dose midazolam | Experimental | Drug: Low dose midazolam |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who need rapid sequence intubation in emergency room
Key exclusion criteria (4 listed)
- in hypotension(systolic blood pressure less than 90 mmHg
- severe trauma patients
- pregnant
- allergic to midazolam, etomidate
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 |
|---|---|---|
| Low dose midazolam | Drug | Low dose midazolam |
Primary outcome
Not reported in the source record.
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 26 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose midazolam in people with Intubation, run by Seoul National University Hospital at 2 sites 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 4 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 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 26 Jul 2011.