Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

Hopital Foch

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Remifentanil; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT00772616

2007/13

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

1

Experimental group

Description:

Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller).

Treatment:

Drug: Remifentanil

2

Active Comparator group

Description:

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

Treatment:

Drug: Sufentanil