Anesthesia, General
Conditions
Brief summary
Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.
Interventions
DRUGmuscle relaxant
muscle relaxant administration throughout anesthesia
DRUGnormal saline
no muscle relaxant throughout anesthesia (normal saline infused as a placebo)
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients scheduled for a surgical procedure which not require a myorelaxation
Exclusion criteria
* age less than 18 years, * ASA III and above, * pregnant woman * combined general and regional anesthesia, * history of prolonged myorelaxation due to a decrease in cholinesterase, * patient with a known lack in cholinesterase, * history of cerebral or psychiatric central, * allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients, * known hypersensitivity to remifentanil or to an other derivative of fentanyl, * presence of a pacemaker, * psychotropic or agonist-antagonist morphine treatment, * planned post-operative sedation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| propofol dose | one hour anesthesia |
Secondary
| Measure | Time frame |
|---|---|
| number of automatic modifications of the propofol and remifentanil concentrations | one hour anesthesia |
| number of patients' movements | one hour anesthesia |
| number of hemodynamic abnormalities requiring treatment | one hour anesthesia |
| remifentanil dose | one hour anesthesia |
| intraoperative awareness | postoperative day 1 or 2 |
| performance of the closed-loop system | one hour anesthesia |
| time to wake up | end of anesthesia |
Countries
France
Outcome results
None listed