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

This study has been terminated.
(recent publication (Ghezel-Ahmadi. Thorac Cardiovasc Surg. 2014 Nov 21))
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01579864
First received: January 4, 2012
Last updated: September 22, 2016
Last verified: September 2016

January 4, 2012
September 22, 2016
January 2012
June 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.
 
Terminated
6
June 2015
June 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01579864
2011/05
No
Not Provided
Not Provided
Hopital Foch
Hopital Foch
Not Provided
Principal Investigator: Morgan Le Guen, MD Hopital Foch
Hopital Foch
September 2016

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