general anesthesia MedDRA version: 9.1 Level: LLT Classification code 10002323 Term: Anesthesia general MedDRA version: 9.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief
Conditions
Interventions
Trade Name: Ultiva
Product Name: Ultiva
Pharmaceutical Form: Powder for infusion*
Trade Name: Sufenta
Product Name: Sufenta
Pharmaceutical Form: Solution for infusion
Trade Name: Morphine
Product Na
Sponsors
Hopital Foch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients scheduled for an abdominal surgery 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age less than 18 years, - Pregnant woman, - Allergy to propofol, sufentanil, remifentanil, morphine, muscle relaxant, or to a component, - Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl, - Inflammatory bowel disease, - Chronic pain, - Patients receiving a psychotropic treatment or a a morphine agonist-antagonist, - Alcoolic patients and patients taking opiates, - History of neurological disorders or central brain lesion, of severe respiratory insufficiency, of hepatic insufficiency, - Emergency surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated BIS-guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. Both systems achieve the same objective: similar level of anesthesia indicated by bispectral index levels between 40 to 60. We make the assumption that this method of automated remifentanil administration may avoid postoperative hyperanalgesia. Patients scheduled for abdominal surgery will be divided into two groups: - in one group, patients will receive automatically delivered propofol and manually delivered sufentanil, - in the other group, patients will receive propofol and remifentanil administered automatically. Assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and depiction of cutaneous hyperalgesia areas. ;Secondary Objective: The secondary objective is the evolution of postoperative pain scores. ;Primary end point(s): Dose of morphine administered postoperatively (patient controlled analgesia) | — |
Countries
France
Outcome results
None listed