Assessment of the Nociception During Lumbar Surgery

NCT ID: NCT01015651

Last Updated: 2010-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-10-31

Brief Summary

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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

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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.

Conditions

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Lumbar Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

remifentanil

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

remifentanil

Intervention Type DRUG

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

Interventions

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remifentanil

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

Intervention Type DRUG

remifentanil

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Anesthesia and Intensive Care, University Hospital, Grenoble

Principal Investigators

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Jean-Francois PAYEN, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital Grenoble

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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2008-A01602-53

Identifier Type: REGISTRY

Identifier Source: secondary_id

0823

Identifier Type: -

Identifier Source: org_study_id

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