Clinical trial NCT03568396: Validation of Pupillary Response to Nociceptive Stimulation in Cardiac Surgery During Extracorporeal Circulation Period
Official title: Validation of Pupillary Response to Nociceptive Stimulation in Cardiac Surgery During Extracorporeal Circulation Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pupil
Analgesics
Opioid Use
Dose-Response Relationship, Drug
Anesthetics, Intravenous
Surgery, Cardiac
Circulation, Extracorporeal
Electric Stimulation
Electroencephalography/Drug Effects
Monitoring, Intraoperative
Adult
Remifentanil
Keywords: Nociceptive stimulation
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting for a general anesthesia for cardiac surgery programmed requiring the realization of a sternotomy and the use of extra corporeal circulation

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation the use of pupillometry as a method of evaluation of nociception in cardiac surgery during the extracorporeal circulation period.
timeFrame: During surgery / one day
Secondary outcomes:
measure: Validity of pupillometry nociception measurements in moderate hypothermia
timeFrame: During surgery / one day
Other outcomes:
measure: Comparison of changes in mean arterial pressure and bispectral index to changes in pupillary diameter
timeFrame: During surgery / one day
Locations:
city: Tours
country: France
facility: Location Anesthesia-Resuscitation Department, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Fabien ESPITALIER, M.D
role: PRINCIPAL_INVESTIGATOR
References: