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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
History of Changes
  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
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • changes in the baroreflex in response to noxious stimuli [ Time Frame: intraoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • perioperative requirements in anesthetic agents. [ Time Frame: intraoperative ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 17, 2009
Last Updated: April 6, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 23, 2013