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Assessment of the Nociception During Lumbar Surgery (CARDEAN-2)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01015651
First received: November 17, 2009
Last updated: April 6, 2010
Last verified: April 2010

November 17, 2009
April 6, 2010
April 2009
October 2009   (final data collection date for primary outcome measure)
changes in the baroreflex in response to noxious stimuli [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01015651 on ClinicalTrials.gov Archive Site
perioperative requirements in anesthetic agents. [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessment of the Nociception During Lumbar Surgery
Assessment of the Nociception During Lumbar Surgery

The aim of the study is to assess the accuracy of a new paradigm in measuring the level of nociception during lumbar surgery. The paradigm is based the measurement of the baroreflex in response to noxious stimuli in anesthetized patients.

The study aims at exploring the changes in the baroreflex induced by 3 noxious stimulation in anesthetized patients: tracheal intubation, tetanic stimulus, and surgical incision. Patients are randomly assigned to one of 2 groups: remifentanil-2 or remifentanil-4, corresponding to the target effect site concentration of this drug delivered through a TCI system. Other drugs included propofol and cisatracurium.

The paradigm exploring the baroreflex collects information continuously recorded of the RR intervals and the changes in systolic arterial pressure, before and during noxious stimuli. The hypothesis is that this paradigm explores nociception as the group with smaller doses in remifentanil will have more cardiovascular reactions in response to noxious stimuli.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Lumbar Surgery
  • Drug: remifentanil
    anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 2 ng/ml.
  • Drug: remifentanil
    anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 4 ng/ml.
  • Active Comparator: remifentanil-2
    In this group, patients are receiving a continuous i.v. infusion of remifentanil according to a target effect site concentration of 2 ng/ml.
    Intervention: Drug: remifentanil
  • Active Comparator: remifentanil-4
    In this group, patients are receiving a continuous i.v. infusion of remifentanil according to a target effect site concentration of 4 ng/ml.
    Intervention: Drug: remifentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA classification I-II
  • undergoing lumbar surgery for discal hernia
  • body mass index <30 kg/m2

Exclusion Criteria:

  • ASA classification III-IV
  • cardiac history that precludes RR recording : atrial fibrillation, arterial hypertension, active cardiac pacing, chronic treatment with beta-blockers, alpha-blockers, calcium-blockers and angiotensin receptors inhibitors
  • diabetes
  • regular intake of cocaine, alcohol
  • pregnancy
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01015651
0823, 2008-A01602-53
No
Jean-Francois PAYEN, Anesthesia and Intensive Care, University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Jean-Francois PAYEN, M.D. University Hospital, Grenoble
University Hospital, Grenoble
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP