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Completed

NCT Number: NCT03568396

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Location Anesthesia-Resuscitation Department, University Hospital, Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pupillometer

Device

Measurement of pupil diameter and reactivity in response to a standard noxious stimulus in cardiac surgery during extracorporeal circulation period.

Primary outcomes

  1. Validation the use of pupillometry as a method of evaluation of nociception in cardiac surgery during the extracorporeal circulation period.

    Time frame: During surgery / one day

    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

Secondary outcomes

  1. Validity of pupillometry nociception measurements in moderate hypothermia

    Time frame: During surgery / one day

    To prove existence of a linear correlation between the change in pupillary diameter and the remifentanil concentration in moderate hypothermia.

Other outcomes

  1. Comparison of changes in mean arterial pressure and bispectral index to changes in pupillary diameter

    Time frame: During surgery / one day

    Compare changes in mean arterial pressure and bispectral index at the time of nociceptive stimulus with changes in pupillary diameter

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: DOLOCEC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2018
Registry last updated
Feb 27, 2019

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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