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Completed

NCT Number: NCT03545308

Pharmacokinetics of Rocuronium for Deep Block (DeepRocu)

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)

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nimes

Nîmes, Gard, 30000, France

About this study

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 %

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

Dose: 1 mg/kg

Primary outcomes

  1. Onset

    Time frame: 3 hour

    The elapsed time (in minute) between Time 0 (injection of rocuronium) to T1 (PTC > 5-7)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Pharmacokinetics of Rocuronium (1 mg/kg) for Deep Block : a Prospective Observational Study

Acronym: DeepRocu

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2018
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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