Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Remifentanil; Drug: Sufentanil

• Registration Number: NCT00772616
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-11
• Study First Submitted QC: 2008-10-11
• Study First Posted: 2008-10-15
• Primary Completion: 2010-01
• Study Completion: 2011-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Remifentanil	Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller).
2	Sufentanil	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

Primary Outcome Measures

Name	Time	Method
Dose of morphine administered during the postoperative period (patient controlled analgesia)	48 postoperative hours

Secondary Outcome Measures

Name	Time	Method
postoperative pain scores	48 postoperative hours
postoperative hyperalgesia	up to 5th to 7th postoperative days
nausea vomiting	48 postoperative hours

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France