Recovery After Sugammadex(Propofol vs Sevoflurane) (Sugammadex2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01579851
First received: January 4, 2012
Last updated: April 19, 2016
Last verified: April 2016
  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:


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,...


Enrollment: 71
Study Start Date: January 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (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   (Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01579851

Locations
France
Hopital Foch
Suresnes, Ile de France, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan Le Guen, MD Hopital Foch
  More Information

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 19, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 25, 2016