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Completed

NCT Number: NCT00772616

Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

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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Key information

Conditions

Anesthesia Agnosia Hyperalgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Foch

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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

Sufentanil

Drug

dosage according to usual criteria

Primary outcomes

  1. Dose of morphine administered during the postoperative period (patient controlled analgesia)

    Time frame: 48 postoperative hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Oct 15, 2008
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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