NCT01579864

Brief Summary

Myorelaxation is generally used as a part of general anesthesia for interventional rigid bronchoscopy. Succinylcholine is most often used because its short duration of action but rocuronium can be used since sugammadex permits a rapid and complete reversal of the neuromuscular block. The aim of ths study is to compare both agents.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

3.4 years

First QC Date

January 4, 2012

Last Update Submit

November 2, 2016

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Score of quality of the surgical procedure

    The quality of the surgical procedure is evaluated by the surgeon (composite score) who is unaware of the neuromuscular agent used (see Fuchs-Buder et al. Acta Anaesthesiol Scand 2007;51(7):789-808)

    one day

Secondary Outcomes (1)

  • Score of quality of anesthesia

    one day

Study Arms (2)

succinylcholine

ACTIVE COMPARATOR

Succinylcholine 1 mg/kg and a second dose if necessary.

Drug: succinylcholine

Rocuronium

EXPERIMENTAL

rocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary

Drug: rocuronium

Interventions

succinylcholineDRUG

Succinylcholine 1 mg/kg and a second dose if necessary. Rocuronium 0,4 mg/kg can be used as a rescue

succinylcholine
rocuroniumDRUG

rocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary

Rocuronium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for an interventional rigid bronchoscopy under general anesthesia

You may not qualify if:

  • pregnant woman or woman of childbearing age,
  • morbid obesity,
  • drug allergy,contra-indication to succinylcholine, rocuronium, sugammadex, propofol, remifentanil,
  • history of central neurological or brain damage,
  • psychotropic treatment,
  • pacemaker,
  • renal failure,
  • disease of the neuromuscular junction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, Île-de-France Region, 92151, France

Location

MeSH Terms

Interventions

SuccinylcholineRocuronium

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsSuccinatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOnium CompoundsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Morgan Le Guen, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

April 18, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

FR(1)