Validation of Pupillary Response to Nociceptive Stimulation in Cardiac Surgery During Extracorporeal Circulation Period

Study Overview
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Brief Summary
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The relationship between the target effect site concentration of remifentanil and the pupil diameter and reactivity in response to a standard noxious stimulus in cardiac surgery during extra corporeal circulation will be evaluated.

Detailed Description
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Anaesthesia will be induced with propofol to obtain loss of consciousness LOC in 30 patients who will undergo cardiac surgery requiring extracorporeal circulation and standardized support will be given to them till the extracorporeal circulation period. Thereafter, remifentanil will be titrated by increments of 0,5, from 1 up to 5 ng ml-1 during the extra corporeal circulation period. In the awake state, at LOC and at each plateau level of remifentanil CeT, mean arterial pressure, and BIS will be recorded. Pupil size and dilatation after a 60 mA, 100 Hz tetanic stimulation will be measured at LOC and at each plateau level of remifentanil.

Official Title
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Validation of Pupillary Response to Nociceptive Stimulation in Cardiac Surgery During Extracorporeal Circulation Period

Conditions
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Pupil, Analgesics, Opioid Use, Dose-Response Relationship, Drug, Anesthetics, Intravenous, Surgery, Cardiac, Circulation, Extracorporeal, Electric Stimulation, Electroencephalography/Drug Effects, Monitoring, Intraoperative, Adult, Remifentanil

Intervention / Treatment
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* Device: Pupillometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: general anesthesia for cardiac surgery programmed requiring the realization of a sternotomy and the use of extra corporeal circulation age> 18 years Exclusion Criteria: contraindication to the use of the products defined in the protocol of anesthesia (alprazolam, remifentanil, propofol, atracurium) sedation in progress with use of morphinomimetics urgent surgery preoperative existence of circulatory assistance preoperative existence of an intra-aortic balloon pump, bilateral ocular pathology (severe cataract, amblyopia, glaucoma, keratitis, conjunctivitis) and / or history of bilateral ocular surgery affecting the iris history of epilepsy, cerebral palsy peripheral neuromuscular diseases pathology with dysautonomia impairing the pupillary dilation reflex: insulin-dependent type 1 or type 2 diabetes with diabetic retinopathy, multiple sclerosis, systemic amyloidosis, uncontrolled hypertension, advanced Parkinson's disease ongoing treatment interfering with the autonomic and central nervous system likely to alter the pupillary dilation reflex: antiemetic (droperidol, metoclopramide), alpha-2 agonist (clonidine, dexmedetomidine), high doses of nitrous oxide treatment with severe anticholinergic effect: such as amitriptyline, amoxapine, atropine, benztropine, chlorpheniramine, chlorpromazine, clemastine, clomipramine, clozapine, darifenacin, desipramine, dicyclomine, diphenhydramine, doxepin, flavoxate, hydroxyzine, hyoscyamine, imipramine, meclizine, nortriptyline, orphenadrine, oxybutynin, paroxetine, perphenazine, procyclidine, promazine, promethazine, propentheline, pyrilamine, scopolamine, thioridazine, tolterodine, trifluoperazine, trihexyphenidyl, trimipramine pregnant or lactating women Patient having objected to the processing of his data

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pupillometry<br>The relationship between the target effect site concentration of remifentanil and the pupil diameter and reactivity in response to a standard noxious stimulus. | Device: Pupillometer<br>* Measurement of pupil diameter and reactivity in response to a standard noxious stimulus in cardiac surgery during extracorporeal circulation period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation the use of pupillometry as a method of evaluation of nociception in cardiac surgery during the extracorporeal circulation period. | To prove the existence of a linear correlation between the change in pupillary diameter and the concentration of remifentanil in cardiac surgery during the extracorporeal circulation period | During surgery / one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of pupillometry nociception measurements in moderate hypothermia | To prove existence of a linear correlation between the change in pupillary diameter and the remifentanil concentration in moderate hypothermia. | During surgery / one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nociceptive stimulation