Assessment of the Nociception During Lumbar Surgery

Lumbar Surgery Clinical Trial

— CARDEAN-2  

Official title:

Assessment of the Nociception During Lumbar Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015651
• Other study ID #: 0823
• Secondary ID: 2008-A01602-53
• Status: Completed
• Phase: N/A
• First received: November 17, 2009
• Last updated: April 6, 2010
• Start date: April 2009
• Est. completion date: October 2009

Study information

• Verified date: April 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lumbar Surgery

Intervention

Drug:
• remifentanil
anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 2 ng/ml.
• remifentanil
anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 4 ng/ml.

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the baroreflex in response to noxious stimuli		intraoperative	No
Secondary	perioperative requirements in anesthetic agents.		intraoperative	No