Succinylcholine or Rocuronium for Rigid Bronchoscopy Under General Anesthesia (Broncho-SR)

This study is currently recruiting participants.
Verified December 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01579864
First received: January 4, 2012
Last updated: December 13, 2013
Last verified: December 2013

January 4, 2012
December 13, 2013
January 2012
January 2015   (final data collection date for primary outcome measure)
Score of quality of the surgical procedure [ Time Frame: one day ] [ Designated as safety issue: No ]
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)
Quality of the surgical procedure [ Time Frame: First postoperative hour ] [ Designated as safety issue: No ]
The qualtity of the surgical procedure is evaluated by the surgeon (composite score) who is unaware of the neuomuscular agent used (see Fuchs-Buder et al. Acta Anaesthesiol Scand 2007;51(7):789-808)
Complete list of historical versions of study NCT01579864 on ClinicalTrials.gov Archive Site
Score of quality of anesthesia [ Time Frame: one day ] [ Designated as safety issue: No ]
The quality of anesthesia is evaluated by the anesthesist in charge on a scale 0-30 (0-10 for the induction ; 0-10 for maintenance; 0-10 for recovery)
Quality of anesthesia [ Time Frame: First postoperative hour ] [ Designated as safety issue: No ]
The quality of anesthesia is evaluated by the anesthesist in charge on a scale 0-30 (0-10 for the induction ; 0-10 for maintenance; 0-10 for recovery)
Not Provided
Not Provided
 
Succinylcholine or Rocuronium for Rigid Bronchoscopy Under General Anesthesia
Interventional Rigid Bronchoscopy Under General Anesthesia: Influence of the Muscle Relaxant, Succinylcholine or Rocuronium, on the Quality of the Surgical Procedure

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Anesthesia
  • Drug: succinylcholine
    Succinylcholine 1 mg/kg and a second dose if necessary. Rocuronium 0,4 mg/kg can be used as a rescue
  • Drug: rocuronium
    rocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary
  • Active Comparator: succinylcholine
    Succinylcholine 1 mg/kg and a second dose if necessary.
    Intervention: Drug: succinylcholine
  • Experimental: Rocuronium
    rocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary
    Intervention: Drug: rocuronium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients scheduled for an interventional rigid bronchoscopy under general anesthesia

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact: Marc Fischler, MD 4652442 ext 0331 m.fischler@hopital-foch.org
France
 
NCT01579864
2011/05
No
Hopital Foch
Hopital Foch
Not Provided
Principal Investigator: Morgan Le Guen, MD Hopital Foch
Hopital Foch
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP