NCT03545308

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
Last Updated

June 4, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

December 29, 2017

Last Update Submit

June 1, 2018

Conditions

Neuromuscular Blockade

Keywords

NeuromuscularDeep AnesthesiaRocuronium

Outcome Measures

Primary Outcomes (1)

  • Onset

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

    3 hour

Secondary Outcomes (4)

  • intubation

    1 hour

  • Post Tetanic Count recovery

    3 hours

  • Recovery Train of Four

    6 hours

  • Antagonization

    6 hours

Interventions

RocuroniumDRUG

Dose: 1 mg/kg

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for surgery under general anesthesia with the need of deep neuromuscular block for surgery

You may qualify if:

  • elective or emergency surgery under general anesthesia with deep block
  • approval
  • adult

You may not qualify if:

  • contra indication to neuromuscular blockade (allergy, myopathy, hyperkaliemia)
  • refusal
  • \< 18 years olds
  • Body mass index \> 50
  • neuropathy
  • regional anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, Gard, 30000, France

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • jean-yves lefrant, MD,PhD

    Centre Hospitalier Universitaire de Nīmes

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor (PhD)

Study Record Dates

First Submitted

December 29, 2017

First Posted

June 4, 2018

Study Start

August 25, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

June 4, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)