AnesthesiaNCT00902070
Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)
An observational study of Anesthesia, run by Merck Sharp & Dohme LLC.
Trial summary
The main purpose of this investigation is to collect safety and efficacy information of Eslax Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as "Eslax") in daily clinical settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia
- What is being tested?
- Rocuronium
- Type of treatment
- Injection or infusion
- How many people
- 3,969 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Oct 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japanese 3000 patients
Who may be able to join
- Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation.
Who cannot join
- Patients with a history of hypersensitivity to Eslax or bromide.
- Patients with myasthenia gravis or myasthenic syndrome.
About this study
Official title: Protocol for Eslax Intravenous Drug Use Investigation
The main purpose of this investigation is to collect safety and efficacy information of Eslax Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as "Eslax") in daily clinical settings.
Read the detailed description
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
- Conditions
- Anesthesia
- Being tested
- Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Eslax
Normally, for adults, 0.6 mg/kg of rocuronium bromide is intravenously administered to support endotracheal intubation. If additional administration is necessary, 0.1 - 0.2 mg/kg is intravenously administered. In the case of continuous infusion, infusion is initiated at a rate of 7 μg/kg/min. Dosage should be adjusted based on the age or symptom. The upper limit of this drug for the intubation is 0.9 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse events
Measured: The standard observation period for a patient is duration of hospital stay (from one week before Eslax administration to one week after administration at a maximum).
Secondary outcomes (2)
intubation score
Measured: From administration of Eslax to completion of intubation
intubation completion time
Measured: From administration of Eslax to completion of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startNov 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,969 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902070
- Sponsor's protocol ID
- P06082
- Status last verified
- Oct 2015
- First submitted
- 13 May 2009
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Eslax Intravenous Drug Use Investigation
- ClinicalTrials.gov ID
- NCT00902070
- Acronym / sponsor ID
- P06082
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,969 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 14 May 2009 (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.
The main purpose of this investigation is to collect safety and efficacy information of Eslax Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as "Eslax") in daily clinical settings.
Detailed description
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: RocuroniumPatients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese 3000 patients
Key inclusion criteria (1 listed)
- Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation.
Key exclusion criteria (2 listed)
- Patients with a history of hypersensitivity to Eslax or bromide.
- Patients with myasthenia gravis or myasthenic syndrome.
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 |
|---|---|---|
| RocuroniumAlso: EslaxNormally, for adults, 0.6 mg/kg of rocuronium bromide is intravenously administered to support endotracheal intubation. If additional administration is necessary, 0.1 - 0.2 mg/kg is intravenously administered. In the case of continuous infusion, infusion is initiated at a rate of 7 μg/kg/min. Dosage should be adjusted based on the age or symptom. The upper limit of this drug for the intubation is 0.9 mg/kg. | Drug | 1 |
Primary outcome
incidence of adverse events
Time frame: The standard observation period for a patient is duration of hospital stay (from one week before Eslax administration to one week after administration at a maximum).
2 secondary outcomes
intubation score
Time frame: From administration of Eslax to completion of intubation
intubation completion time
Time frame: From administration of Eslax to completion of intubation
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 30 Oct 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Merck Sharp & Dohme LLC.
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 2 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 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
incidence of adverse events (time frame: The standard observation period for a patient is duration of hospital stay (from one week before Eslax administration to one week after administration at a maximum).). 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 30 Oct 2015.