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Completed

NCT Number: NCT01579851

Recovery After Sugammadex(Propofol vs 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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Foch

Suresnes, Île-de-France Region, 92151, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugammadex

Drug

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

Primary outcomes

  1. 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

  2. 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 outcomes

  1. T4/T1 ratio after sugammadex injection

    Time frame: One hour after anesthesia

    Modification of T4/T1 ratio after sugammadex injection

  2. 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,...

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)

Acronym: Sugammadex2

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 18, 2012
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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