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Recovery After Sugammadex(Propofol vs Sevoflurane) (Sugammadex2)

This study is currently recruiting participants.
Verified May 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01579851
First received: January 4, 2012
Last updated: May 19, 2013
Last verified: May 2013
History of Changes

January 4, 2012
May 19, 2013
January 2012
May 2014   (final data collection date for primary outcome measure)
  • Number of patients with an increase in Bispectral Index after sugammadex injection [ Time Frame: One hour after anesthesia ] [ Designated as safety issue: No ]
    Increase in Bispectral Index (> 20) after sugammadex injection
  • Number of patients with occurence of clinical signs of awakening after sugammadex injection [ Time Frame: One hour after anesthesia ] [ Designated as safety issue: No ]
    Clinical signs of awakening after sugammadex are wallowing, eye opening on demand, cough, spontaneous movements, response to simple commands, tearing, ...
Same as current
Complete list of historical versions of study NCT01579851 on ClinicalTrials.gov Archive Site
  • T4/T1 ratio after sugammadex injection [ Time Frame: One hour after anesthesia ] [ Designated as safety issue: No ]
    Modification of T4/T1 ratio after sugammadex injection
  • Number of patients with side effects due to sugammadex injection [ Time Frame: One hour after anesthesia ] [ Designated as safety issue: No ]
    Side effects after sugammadex injection are bradycardia, nausea or vomiting, pain, residual curarisation, awareness,...
Same as current
Not Provided
Not Provided
 
Recovery After Sugammadex(Propofol vs Sevoflurane)
Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)

Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia
Drug: Sugammadex

sugammadex

  • 4 mg/kg : if there is no response to Train of Four stimulations and at least one response to the Post Tetanic Count
  • 2 mg/kg : if there is at least two responses to Train of Four stimulations
  • Active Comparator: Propofol-Remifentanil
    Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium
    Intervention: Drug: Sugammadex
  • Active Comparator: Sevoflurane-Remifentanil
    Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium
    Intervention: Drug: Sugammadex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients scheduled to receive general anesthesia with muscle relaxation achieved with rocuronium

Exclusion Criteria:

  • Known drug allergy,
  • Contra-indications to the use of propofol, remifentanil, rocuronium, sevoflurane, sugammadex
  • Difficulty to use Bispectral Index monitor
  • Inability to obtain a proper monitoring of muscle relaxation.
Both
18 Years and older
No
Contact: Marc Fischler, MD 4652442 ext 0331 m.fischler@hopital-foch.org
France
 
NCT01579851
2010/58
No
Hopital Foch
Hopital Foch
Not Provided
Principal Investigator: Morgan Le Guen, MD Hopital Foch
Hopital Foch
May 2013

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