Assessment of the Nociception During Lumbar Surgery (CARDEAN-2)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
|Official Title:||Assessment of the Nociception During Lumbar Surgery|
- changes in the baroreflex in response to noxious stimuli [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
- perioperative requirements in anesthetic agents. [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
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.
anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 2 ng/ml.
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.
anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 4 ng/ml.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015651
|University Hospital Grenoble|
|Grenoble, France, 38043|
|Principal Investigator:||Jean-Francois PAYEN, M.D.||University Hospital, Grenoble|