Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-01-31

Brief Summary

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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:

* 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.

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Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

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

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

closed-loop administration using bispectral index as the single input for the controller.

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

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

dosage according to usual criteria

Interventions

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Remifentanil

closed-loop administration using bispectral index as the single input for the controller.

Intervention Type DRUG

Sufentanil

dosage according to usual criteria

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No