Anesthesia
Conditions
Keywords
Anesthesia
Brief summary
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia
Interventions
DRUGPropofol
closed-loop administration using bispectral index as the controller
DRUGremifentanil
closed-loop administration using bispectral index as the controller
DRUGRemifentanil
manual administration according bispectral index values
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* class ASA I, II or III * general anesthesia scheduled to last more than one hour * intraoperative hemorrhage planned to be less than 15% of the blood volume
Exclusion criteria
* Combined general and regional anesthesia, * Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure, * History of a neurological or a psychiatric disorder, or central brain lesion, * Patients receiving a psychotropic treatment or a a morphine agonist-antagonist, * Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component, * Hypersensibility to remifentanil or to a derivate of fentanyl, * Scheduled postoperative ventilation or sedation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time during which the bispectral index is between 40 and 60 | anesthesia |
Secondary
| Measure | Time frame |
|---|---|
| propofol and remifentanil doses | anesthesia |
Countries
France
Outcome results
None listed