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

June 1, 2018 updated by: Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes

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

Status

Completed

Intervention / Treatment

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

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gard
      • Nîmes, Gard, France, 30000
        • CHU Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: jean-yves Lefrant, MD,PhD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

June 1, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

June 4, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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