Neuromuscular BlockadeDeepRocuNCT03545308
Pharmacokinetics of Rocuronium for Deep Block (DeepRocu)
An observational study of Neuromuscular Blockade, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Rocuronium is a non-depolarising neuromuscular blocking agent. The compound has a rapid onset and an intermediate duration of action. The rapid onset is of importance in patients at risk for pulmonary aspiration, for elective induction of anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Rocuronium
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 25 Aug 2017to 1 Mar 2018
- 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 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled for surgery under general anesthesia with the need of deep neuromuscular block for surgery
Who may be able to join
- elective or emergency surgery under general anesthesia with deep block
- approval
- adult
Who cannot join
- contra indication to neuromuscular blockade (allergy, myopathy, hyperkaliemia)
- refusal
- < 18 years olds
- Body mass index > 50
- neuropathy
- regional anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Rocuronium (1 mg/kg) for Deep Block : a Prospective Observational Study
Rocuronium is a non-depolarising neuromuscular blocking agent. The compound has a rapid onset and an intermediate duration of action.
The rapid onset is of importance in patients at risk for pulmonary aspiration, for elective induction of anesthesia. Clinical studies simulating rapid sequence induction in elective patients indicate that rocuronium 0.9 mg kg-1 may be suitable for crash intubation.Also, rocuronium may be an alternative to succinylcholine for rapid sequence induction when high dose is injected (3x Effective Dose 95 %= 1mg/kg). But, pharmacokinetic of rocuronium at 1 mg/kg is not well establish.
The investigator investigate the onset and recovery of a single dose rocuronium (1 mg/kg) in consecutive patients (>100) using adductor muscle monitoring (Train of Four and Post Tetanic Count)
Read the detailed description
In this study, pharmacokinetic of rocuronium at 1 mg/kg will be evaluated at each point of Train of Four Response (TOF) and Post Tetanic Count (when TOF=0) troughout the period of anesthesia and surgery.
Time 0 is the time of rocuronium injection, Time 1 is the time when post tetanic count is > 5-7 and TOF=0, Time 3 when TOF >0 response, Time 4 when 4 reponses of the TOF and Time 5 when TOF > 90 %
- Conditions
- Neuromuscular Blockade
- Being tested
- Rocuronium
- Keywords
- Neuromuscular, Deep Anesthesia, Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Dose: 1 mg/kg
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset
The elapsed time (in minute) between Time 0 (injection of rocuronium) to T1 (PTC > 5-7)
Measured: 3 hour
Secondary outcomes (4)
intubation
time for intubation
Measured: 1 hour
Post Tetanic Count recovery
Times between Post Tetanic Count = 0 to 20 (Time 3)
Measured: 3 hours
Recovery Train of Four
Times between T0 to train of four= 4 (Time 4)
Measured: 6 hours
Antagonization
Evaluation of recovery with sugammadex or prostigmine
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start25 Aug 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes
- Investigators
- jean-yves lefrant, MD,PhD, Study chair, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545308
- Sponsor's protocol ID
- 2016-01-01
- Acronym
- DeepRocu
- Status last verified
- Jun 2018
- First submitted
- 29 Dec 2017
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Rocuronium (1 mg/kg) for Deep Block : a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03545308
- Acronym / sponsor ID
- DeepRocu / 2016-01-01
- Conditions
- Neuromuscular Blockade
- Keywords
- Neuromuscular, Deep Anesthesia, Rocuronium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 4 Jun 2018 (actual)
- 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.
Rocuronium is a non-depolarising neuromuscular blocking agent. The compound has a rapid onset and an intermediate duration of action.
The rapid onset is of importance in patients at risk for pulmonary aspiration, for elective induction of anesthesia. Clinical studies simulating rapid sequence induction in elective patients indicate that rocuronium 0.9 mg kg-1 may be suitable for crash intubation.Also, rocuronium may be an alternative to succinylcholine for rapid sequence induction when high dose is injected (3x Effective Dose 95 %= 1mg/kg). But, pharmacokinetic of rocuronium at 1 mg/kg is not well establish.
The investigator investigate the onset and recovery of a single dose rocuronium (1 mg/kg) in consecutive patients (>100) using adductor muscle monitoring (Train of Four and Post Tetanic Count)
Detailed description
In this study, pharmacokinetic of rocuronium at 1 mg/kg will be evaluated at each point of Train of Four Response (TOF) and Post Tetanic Count (when TOF=0) troughout the period of anesthesia and surgery.
Time 0 is the time of rocuronium injection, Time 1 is the time when post tetanic count is > 5-7 and TOF=0, Time 3 when TOF >0 response, Time 4 when 4 reponses of the TOF and Time 5 when TOF > 90 %
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery under general anesthesia with the need of deep neuromuscular block for surgery
Key inclusion criteria (3 listed)
- elective or emergency surgery under general anesthesia with deep block
- approval
- adult
Key exclusion criteria (6 listed)
- contra indication to neuromuscular blockade (allergy, myopathy, hyperkaliemia)
- refusal
- < 18 years olds
- Body mass index > 50
- neuropathy
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 |
|---|---|---|
| RocuroniumDose: 1 mg/kg | Drug | – |
Primary outcome
Onset
Time frame: 3 hour
The elapsed time (in minute) between Time 0 (injection of rocuronium) to T1 (PTC > 5-7)
4 secondary outcomes
intubation
Time frame: 1 hour
Post Tetanic Count recovery
Time frame: 3 hours
Recovery Train of Four
Time frame: 6 hours
Antagonization
Time frame: 6 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 4 Jun 2018.
- Individual participant dataSharing planned: No
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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.
jean-yves lefrant, MD,PhD study chair
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 6 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 4 Jun 2018. 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 France. 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 frame: 3 hour). 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 4 Jun 2018.