Succinylcholine or Rocuronium for Rigid Bronchoscopy Under General Anesthesia

Anesthesia Clinical Trial

— Broncho-SR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01579864
• Other study ID #: 2011/05
• Secondary ID: 2011-000370-59
• Status: Terminated
• Phase: Phase 4
• First received: January 4, 2012
• Last updated: November 2, 2016
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• succinylcholine
Succinylcholine 1 mg/kg and a second dose if necessary. Rocuronium 0,4 mg/kg can be used as a rescue
• rocuronium
rocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of quality of the surgical procedure	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)	one day	No
Secondary	Score of quality of anesthesia	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)	one day	No