Pharmacokinetics of Rocuronium for Deep Block (DeepRocu)

NCT ID: NCT03545308

Last Updated: 2018-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-25

Study Completion Date

2018-03-01

Brief Summary

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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

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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

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Neuromuscular Blockade

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Rocuronium

Dose: 1 mg/kg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Philippe Cuvillon

Clinical Professor (PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jean-yves lefrant, MD,PhD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire de Nīmes

Locations

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CHU Nimes

Nîmes, Gard, France

Site Status

Countries

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France

Other Identifiers

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2016-01-01

Identifier Type: -

Identifier Source: org_study_id

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