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Completed

NCT Number: NCT01015651

Assessment of the Nociception During Lumbar Surgery

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.

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Key information

Conditions

Lumbar Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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

Primary outcomes

  1. changes in the baroreflex in response to noxious stimuli

    Time frame: intraoperative

Secondary outcomes

  1. perioperative requirements in anesthetic agents.

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: CARDEAN-2

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 18, 2009
Registry last updated
Apr 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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