- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03545308
Pharmacokinetics of Rocuronium for Deep Block (DeepRocu) (DeepRocu)
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)
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gard
-
Nîmes, Gard, France, 30000
- CHU Nîmes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- elective or emergency surgery under general anesthesia with deep block
- approval
- adult
Exclusion Criteria:
- contra indication to neuromuscular blockade (allergy, myopathy, hyperkaliemia)
- refusal
- < 18 years olds
- Body mass index > 50
- neuropathy
- regional anesthesia
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Onset
Time Frame: 3 hour
|
The elapsed time (in minute) between Time 0 (injection of rocuronium) to T1 (PTC > 5-7)
|
3 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intubation
Time Frame: 1 hour
|
time for intubation
|
1 hour
|
Post Tetanic Count recovery
Time Frame: 3 hours
|
Times between Post Tetanic Count = 0 to 20 (Time 3)
|
3 hours
|
Recovery Train of Four
Time Frame: 6 hours
|
Times between T0 to train of four= 4 (Time 4)
|
6 hours
|
Antagonization
Time Frame: 6 hours
|
Evaluation of recovery with sugammadex or prostigmine
|
6 hours
|
Collaborators and Investigators
Investigators
- Study Chair: jean-yves Lefrant, MD,PhD, Centre Hospitalier Universitaire de Nîmes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-01-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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