perioperative analgesia MedDRA version: 12.1 Level: LLT Classification code 10054799 Term: Perioperative analgesia
Conditions
Interventions
Trade Name: ULTIVA
Product Name: remifentanil
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
CHU de SAINT-ETIENNE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 to 55 years old ASA status 1 or 2 Patients scheduled to undergo general anesthesia for different types of surgery (neurosurgical or medular surgery, ear, nose or throat surgery or orthopedic surgery) Gived informed consent before the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: patient admit to emergency surgery or to eye surgery patient with propofol allergy or remifentanil allergy Patient who has had a anesthesia between the 7 days before the study Patient with a pacemaker Patient with a transplant heart Patient with previous history of parkinson disease, of diabetes, of chonic ethylism, Patient with cardiac or autonomic disease Patient with alpha or beta bloquant treatment Patient with anti arythmic treatment Patient allergic to soy or to peanut Hypersensitivity to fentanyl derivatives or to one or mors Ultiva and Propofol excipient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the relationship between the calculated Cet of remifentanil and the parameters from HRV et APV before a standard noxious stimulation during general anesthesia at calibrated hypnosis level;Secondary Objective: 1. To investigate the relationship between calculated Cet of remifentanil and parameters from HRV and APV after a standard noxious stimulation during general anesthesia at calibrated hypnosis level. 2. To investigate the relationship between parameters from HRV and APV and pupil size or dilatation before a standard noxious stimulation during general anesthesia at calibrated hypnosis level. 3. To investigate the relationship between parameters from HRV and APV and pupil size or dilatation after a standard noxious stimulation during general anesthesia at calibrated hypnosis level. 4. The changes in BIS and haemodynamic measurements will also be recorded and compared with parameters from HRV and APV and pupil size or dilatation to determine the probability of these parameters to predict a haemodynamic response or a movement during calibrated noxious stimulation. ;Primary end point(s): Relationship between LFVFC (a low frequency region = sympathetic activity), HFVPA higt frequency region = parasympathetic activity), LFVPA (sympathetic activity), HFVPA (parasympathetic activity) and opioid cerebral concentrations before and after nociceptive stimulation | — |
Countries
France
Outcome results
None listed