NCT03568396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 22, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

June 8, 2018

Last Update Submit

February 26, 2019

Conditions

PupilAnalgesicsOpioid UseDose-Response Relationship, DrugAnesthetics, IntravenousSurgery, CardiacCirculation, ExtracorporealElectric StimulationElectroencephalography/Drug EffectsMonitoring, IntraoperativeAdultRemifentanil

Keywords

Nociceptive stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Validity of pupillometry nociception measurements in moderate hypothermia

    During surgery / one day

Other Outcomes (1)

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

    During surgery / one day

Study Arms (1)

Pupillometry

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

Interventions

PupillometerDEVICE

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

Pupillometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • general anesthesia for cardiac surgery programmed requiring the realization of a sternotomy and the use of extra corporeal circulation
  • age\> 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Location Anesthesia-Resuscitation Department, University Hospital, Tours

Tours, 37044, France

Location

Study Officials

  • Fabien ESPITALIER, M.D

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 26, 2018

Study Start

August 22, 2018

Primary Completion

October 25, 2018

Study Completion

October 25, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)