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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Lumbar Surgery

Treatments: Drug: remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01015651

2008-A01602-53 (Registry Identifier)

0823

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

remifentanil-2

Active Comparator group

Description:

In this group, patients are receiving a continuous i.v. infusion of remifentanil according to a target effect site concentration of 2 ng/ml.

Treatment:

Drug: remifentanil

Drug: remifentanil

remifentanil-4

Active Comparator group

Description:

In this group, patients are receiving a continuous i.v. infusion of remifentanil according to a target effect site concentration of 4 ng/ml.

Treatment:

Drug: remifentanil

Drug: remifentanil