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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:
Assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller). |
|
| 2 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | closed-loop administration using bispectral index as the single input for the controller. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose of morphine administered during the postoperative period (patient controlled analgesia) | 48 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain scores | 48 postoperative hours | |
| postoperative hyperalgesia | up to 5th to 7th postoperative days | |
| nausea vomiting |
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Inclusion Criteria:
- Patients scheduled for an abdominal surgery
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hopital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | 92150 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15983467 | Background | 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. | |
| 16571963 | Background | 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Sufentanil | Drug | dosage according to usual criteria |
|
| 48 postoperative hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005283 | Fentanyl |