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Recovery After Sugammadex(Propofol vs Sevoflurane) (Sugammadex2)

This study is currently recruiting participants.
Verified April 2012 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01579851
First received: January 4, 2012
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Anesthesia
 Drug: Sugammadex
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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, ...


Secondary Outcome Measures:
  • 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,...


Estimated Enrollment: 70
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol-Remifentanil
Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium
 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: Sevoflurane-Remifentanil
Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579851

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    
Principal Investigator: Morgan Le Guen, MD            
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: NCT01579851     History of Changes
Other Study ID Numbers: 2010/58
Study First Received: January 4, 2012
Last Updated: April 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Propofol
Remifentanil
Sevoflurane
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 17, 2012