Clinical trial NCT00772616: Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Anesthesia
Analgesia
Patient-Controlled Analgesia
Hyperalgesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Dose of morphine administered during the postoperative period (patient controlled analgesia)
timeFrame: 48 postoperative hours
Secondary outcomes:
measure: postoperative pain scores
timeFrame: 48 postoperative hours
measure: postoperative hyperalgesia
timeFrame: up to 5th to 7th postoperative days
measure: nausea vomiting
timeFrame: 48 postoperative hours
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.
citation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.