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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01579864
Recruitment Status : Terminated (recent publication (Ghezel-Ahmadi. Thorac Cardiovasc Surg. 2014 Nov 21))
First Posted : April 18, 2012
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: succinylcholine Drug: rocuronium Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Interventional Rigid Bronchoscopy Under General Anesthesia: Influence of the Muscle Relaxant, Succinylcholine or Rocuronium, on the Quality of the Surgical Procedure
Study Start Date : January 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: succinylcholine
Succinylcholine 1 mg/kg and a second dose if necessary.
 Drug: succinylcholine
Succinylcholine 1 mg/kg and a second dose if necessary. Rocuronium 0,4 mg/kg can be used as a rescue
Experimental: Rocuronium
rocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary
 Drug: rocuronium
rocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary


Outcome Measures
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Primary Outcome Measures :
  1. Score of quality of the surgical procedure [ Time Frame: one day ]
    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)


Secondary Outcome Measures :
  1. Score of quality of anesthesia [ Time Frame: one day ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579864


Locations
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France
Hopital Foch
Suresnes, Ile de France, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Morgan Le Guen, MD Hopital Foch
More Information
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01579864    
Other Study ID Numbers: 2011/05
2011-000370-59 ( EudraCT Number )
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Rocuronium
Succinylcholine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neuromuscular Depolarizing Agents