Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

Sponsor

Hopital Foch (Other)

Overall Status

Completed

CT.gov ID

NCT00772616

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Remifentanil Drug: Sufentanil	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

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 Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller).	Drug: Remifentanil closed-loop administration using bispectral index as the single input for the controller.
Active Comparator: 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	Drug: Sufentanil dosage according to usual criteria

Arm

Intervention/Treatment

Experimental: 1

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

Drug: Remifentanil

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

Active Comparator: 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

Drug: Sufentanil

dosage according to usual criteria

Outcome Measures

Primary Outcome Measures

Dose of morphine administered during the postoperative period (patient controlled analgesia) [48 postoperative hours]

Secondary Outcome Measures

postoperative pain scores [48 postoperative hours]
postoperative hyperalgesia [up to 5th to 7th postoperative days]
nausea vomiting [48 postoperative hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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