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

This study is currently recruiting participants.
Verified May 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01579864
First received: January 4, 2012
Last updated: May 19, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Anesthesia
 Drug: succinylcholine
Drug: rocuronium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579864

Contacts
Contact: Marc Fischler, MD 4652442 ext 0331 m.fischler@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, Ile de France, France, 92151
Contact: Morgan Le Guen, MD     46252442 ext 00331     m.leguen@hopital-foch.org    
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan Le Guen, MD Hopital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01579864     History of Changes
Other Study ID Numbers: 2011/05
Study First Received: January 4, 2012
Last Updated: May 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics
Succinylcholine
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Neuromuscular Nondepolarizing Agents

ClinicalTrials.gov processed this record on June 17, 2013