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Pharmacokinetics of Rocuronium for Deep Block (DeepRocu) (DeepRocu)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03545308
Recruitment Status : Completed
First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief 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. 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

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
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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Rocuronium
    Dose: 1 mg/kg

Outcome Measures
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Primary Outcome Measures :
  1. Onset [ Time Frame: 3 hour ]
    The elapsed time (in minute) between Time 0 (injection of rocuronium) to T1 (PTC > 5-7)


Secondary Outcome Measures :
  1. intubation [ Time Frame: 1 hour ]
    time for intubation

  2. Post Tetanic Count recovery [ Time Frame: 3 hours ]
    Times between Post Tetanic Count = 0 to 20 (Time 3)

  3. Recovery Train of Four [ Time Frame: 6 hours ]
    Times between T0 to train of four= 4 (Time 4)

  4. Antagonization [ Time Frame: 6 hours ]
    Evaluation of recovery with sugammadex or prostigmine


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for surgery under general anesthesia with the need of deep neuromuscular block for surgery
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
CHU Nimes
Nîmes, Gard, France, 30000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Chair: jean-yves lefrant, MD,PhD Centre Hospitalier Universitaire de Nīmes
More Information
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Responsible Party: Philippe Cuvillon, Clinical Professor (PhD), Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03545308    
Other Study ID Numbers: 2016-01-01
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes:
Neuromuscular
Deep Anesthesia
Rocuronium
Additional relevant MeSH terms:
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Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs