Influence of Intraoperative Analgesia (Sufentanil Administered According to the Usual Criteria or Remifentanil Administered by a Closed-loop System Using Bispectral Index as the Controller) on the Postoperative Morphine Consumption
Overview
- Phase
- Phase 4
- Intervention
- Remifentanil
- Conditions
- Anesthesia
- Sponsor
- Hopital Foch
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Dose of morphine administered during the postoperative period (patient controlled analgesia)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated bispectral index - 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 hyperalgesia. Patients scheduled for abdominal surgery will be divided into two groups:
- in one group, patients will receive automatically delivered propofol and manually delivered sufentanil according to the usual criteria,
- in the other group, patients will receive propofol and remifentanil both automatically administered.
Assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled for an abdominal surgery
Exclusion Criteria
- •Age less than 18 years,
- •Pregnant women,
- •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,
- •Alcoholic patients and patients taking opiates,
- •History of neurological disorders or central brain lesion, of severe respiratory insufficiency, of hepatic insufficiency,
- •Emergency surgery
Arms & Interventions
1
Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller).
Intervention: Remifentanil
2
Patients will receive propofol automatically administered (closed-loop administration using bispectral index as the single input for the controller) and sufentanil according to usual criteria
Intervention: Sufentanil
Outcomes
Primary Outcomes
Dose of morphine administered during the postoperative period (patient controlled analgesia)
Time Frame: 48 postoperative hours
Secondary Outcomes
- postoperative pain scores(48 postoperative hours)
- postoperative hyperalgesia(up to 5th to 7th postoperative days)
- nausea vomiting(48 postoperative hours)