Recovery After Sugammadex(Propofol vs Sevoflurane)

Study Overview
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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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Sugammadex


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol-Remifentanil<br>Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium | Drug: Sugammadex<br>* 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<br>|
| Active Comparator: Sevoflurane-Remifentanil<br>Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium | Drug: Sugammadex<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with an increase in Bispectral Index after sugammadex injection | Increase in Bispectral Index (> 20) after sugammadex injection | One hour after anesthesia | 
| Number of patients with occurence of clinical signs of awakening after sugammadex injection | Clinical signs of awakening after sugammadex are wallowing, eye opening on demand, cough, spontaneous movements, response to simple commands, tearing, ... | One hour after anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T4/T1 ratio after sugammadex injection | Modification of T4/T1 ratio after sugammadex injection | One hour after anesthesia | 
| Number of patients with side effects due to sugammadex injection | Side effects after sugammadex injection are bradycardia, nausea or vomiting, pain, residual curarisation, awareness,... | One hour after anesthesia |