Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00772616
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Remifentanil Drug: Sufentanil Phase 4

Study Type : Interventional  (Clinical Trial)
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 : September 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

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

Primary Outcome Measures :
  1. Dose of morphine administered during the postoperative period (patient controlled analgesia) [ Time Frame: 48 postoperative hours ]

Secondary Outcome Measures :
  1. postoperative pain scores [ Time Frame: 48 postoperative hours ]
  2. postoperative hyperalgesia [ Time Frame: up to 5th to 7th postoperative days ]
  3. nausea vomiting [ Time Frame: 48 postoperative hours ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00772616

Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Study Chair: Marc Fischler, MD Hopital Foch

Responsible Party: Hopital Foch Identifier: NCT00772616     History of Changes
Other Study ID Numbers: 2007/13
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by Hopital Foch:
Patient-Controlled Analgesia

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia