Assessment of the Nociception During Lumbar Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01015651

Acronym

CARDEAN-2

Enrollment

Registered

2009-11-18

Start date

2009-04-30

Completion date

2009-10-31

Last updated

2010-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Surgery

Keywords

nociception, intraoperative, baroreflex

Brief 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.

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.

Interventions

DRUGremifentanil

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
changes in the baroreflex in response to noxious stimuli	intraoperative

Secondary

Measure	Time frame
perioperative requirements in anesthetic agents.	intraoperative

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026