Anesthesia, General
Conditions
Brief summary
The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).
Interventions
DEVICEClosed loop anesthesia
Propofol and Remifentanil are administered automatically using a closed-loop system
Sponsors
Hopital Foch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing scheduled surgery under general anesthesia, agreeing to participate in the study
Exclusion criteria
* Age under 18 years * Pregnancy, breastfeeding woman * Allergy to propofol, soybeans or peanuts * Allergy to sufentanil, remifentanil, morphine, * Allergy to a muscle relaxant or to any of its excipients * Known hypersensitivity to sufentanil, remifentanil, or to other derivates of fentanyl * History of central neurological disorder or brain injury * Patient with dementia * Patient with pacemaker * Patient receiving psychotropic drugs or morphine agonist-antagonists * Surgery on the skull and/or operating position preventing the use of a bispectral index sensor in suitable conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia | during anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remifentanil dose required for anesthesia induction | intraoperative period | — |
| Remifentanil dose requirements for maintenance of anesthesia | intraoperative period | — |
| Wake up time | intraoperative period | — |
| Explicit memorisation | post-operative period | — |
| Propofol dose required for anesthesia induction | intraoperative period | — |
| Analysis of subgroup of patients according to their clinical status | post-operative period | analysis of subgroup of patients according to their clinical status (eg: age) |
| Analysis of subgroup of patients according to the surgical approach | post-operative period | analysis of subgroup of patients according to the surgical approach (open surgery versus minimal invasive surgery) |
| Analysis of subgroup of patients according to their pathology | post-operative period | analysis of subgroup of patients according to their pathology (eg: burns) |
| Propofol and remifentanil requirements according to the surgical technique | post-operative period | — |
Countries
France
Outcome results
None listed