Pharmacokinetics of Rocuronium for Deep Block (DeepRocu) (DeepRocu)
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|ClinicalTrials.gov Identifier: NCT03545308|
Recruitment Status : Completed
First Posted : June 4, 2018
Last Update Posted : June 4, 2018
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)
|Condition or disease||Intervention/treatment|
|Neuromuscular Blockade||Drug: Rocuronium|
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 :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||Pharmacokinetics of Rocuronium (1 mg/kg) for Deep Block : a Prospective Observational Study|
|Actual Study Start Date :||August 25, 2017|
|Actual Primary Completion Date :||March 1, 2018|
|Actual Study Completion Date :||March 1, 2018|
- Drug: Rocuronium
Dose: 1 mg/kg
- Onset [ Time Frame: 3 hour ]The elapsed time (in minute) between Time 0 (injection of rocuronium) to T1 (PTC > 5-7)
- intubation [ Time Frame: 1 hour ]time for intubation
- Post Tetanic Count recovery [ Time Frame: 3 hours ]Times between Post Tetanic Count = 0 to 20 (Time 3)
- Recovery Train of Four [ Time Frame: 6 hours ]Times between T0 to train of four= 4 (Time 4)
- Antagonization [ Time Frame: 6 hours ]Evaluation of recovery with sugammadex or prostigmine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545308
|Nîmes, Gard, France, 30000|
|Study Chair:||jean-yves lefrant, MD,PhD||Centre Hospitalier Universitaire de Nīmes|