Anesthesia
Conditions
Brief summary
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.
Interventions
DRUGSugammadex
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
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with an increase in Bispectral Index after sugammadex injection | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| T4/T1 ratio after sugammadex injection | One hour after anesthesia | Modification of T4/T1 ratio after sugammadex injection |
| Number of patients with side effects due to sugammadex injection | One hour after anesthesia | Side effects after sugammadex injection are bradycardia, nausea or vomiting, pain, residual curarisation, awareness,... |
Countries
France
Outcome results
None listed