Assessment of the Nociception During Lumbar Surgery (CARDEAN-2)
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|ClinicalTrials.gov Identifier: NCT01015651|
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : April 7, 2010
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Surgery||Drug: remifentanil||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Assessment of the Nociception During Lumbar Surgery|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
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.
- changes in the baroreflex in response to noxious stimuli [ Time Frame: intraoperative ]
- perioperative requirements in anesthetic agents. [ Time Frame: intraoperative ]
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 ClinicalTrials.gov identifier (NCT number): NCT01015651
|University Hospital Grenoble|
|Grenoble, France, 38043|
|Principal Investigator:||Jean-Francois PAYEN, M.D.||University Hospital, Grenoble|