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Recovery After Sugammadex(Propofol vs Sevoflurane) (Sugammadex2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579851
First Posted: April 18, 2012
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
    Modification of T4/T1 ratio after sugammadex injection

  • Number of patients with side effects due to sugammadex injection [ Time Frame: One hour after anesthesia ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
2010-023943-13 ( EudraCT Number )
First Submitted: January 4, 2012
First Posted: April 18, 2012
Last Update Posted: May 22, 2017
Last Verified: May 2017

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