Recovery After Sugammadex(Propofol vs Sevoflurane)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propofol-Remifentanil

Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type 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

Sevoflurane-Remifentanil

Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No