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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


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
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