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

Tracking Information

First Received Date ^ICMJE

January 4, 2012

Last Updated Date

May 19, 2013

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01579864 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Succinylcholine or Rocuronium for Rigid Bronchoscopy Under General Anesthesia

Official Title ^ICMJE

Interventional Rigid Bronchoscopy Under General Anesthesia: Influence of the Muscle Relaxant, Succinylcholine or Rocuronium, on the Quality of the Surgical Procedure

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Anesthesia

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Marc Fischler, MD

4652442 ext 0331

m.fischler@hopital-foch.org

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01579864

Other Study ID Numbers ^ICMJE

2011/05

Has Data Monitoring Committee

Responsible Party

Hopital Foch

Study Sponsor ^ICMJE

Hopital Foch

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Morgan Le Guen, MD

Hopital Foch

Information Provided By

Hopital Foch

Verification Date

May 2013

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

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