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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01015651
First Posted: November 18, 2009
Last Update Posted: April 7, 2010
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.
Information provided by:
University Hospital, Grenoble
  Purpose
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.

Condition Intervention
Lumbar Surgery Drug: remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Assessment of the Nociception During Lumbar Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • changes in the baroreflex in response to noxious stimuli [ Time Frame: intraoperative ]

Secondary Outcome Measures:
  • perioperative requirements in anesthetic agents. [ Time Frame: intraoperative ]

Enrollment: 16
Study Start Date: April 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: remifentanil
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.
Drug: remifentanil
anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 4 ng/ml.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01015651


Locations
France
University Hospital Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Francois PAYEN, M.D. University Hospital, Grenoble
  More Information

Responsible Party: Jean-Francois PAYEN, Anesthesia and Intensive Care, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01015651     History of Changes
Other Study ID Numbers: 0823
2008-A01602-53 ( Registry Identifier: ID RCB )
First Submitted: November 17, 2009
First Posted: November 18, 2009
Last Update Posted: April 7, 2010
Last Verified: April 2010

Keywords provided by University Hospital, Grenoble:
nociception, intraoperative, baroreflex

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