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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03568396
Acronym
DOLOCEC
Enrollment
30
Registered
2018-06-26
Start date
2018-08-22
Completion date
2018-10-25
Last updated
2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Nociceptive stimulation

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.

Interventions

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

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Validation the use of pupillometry as a method of evaluation of nociception in cardiac surgery during the extracorporeal circulation period.During surgery / one dayTo 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

MeasureTime frameDescription
Validity of pupillometry nociception measurements in moderate hypothermiaDuring surgery / one dayTo prove existence of a linear correlation between the change in pupillary diameter and the remifentanil concentration in moderate hypothermia.

Other

MeasureTime frameDescription
Comparison of changes in mean arterial pressure and bispectral index to changes in pupillary diameterDuring surgery / one dayCompare changes in mean arterial pressure and bispectral index at the time of nociceptive stimulus with changes in pupillary diameter

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026