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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use; Remifentanil; Adult; Analgesics; Electric Stimulation; Anesthetics, Intravenous; Surgery, Cardiac; Monitoring, Intraoperative; Pupil; Dose-Response Relationship, Drug; Circulation, Extracorporeal; Electroencephalography/Drug Effects
• Intervention / Treatment: Device: Pupillometer

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Location Anesthesia-Resuscitation Department, University Hospital, Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Measurement of pupil diameter and reactivity in response to a standard noxious stimulus in cardiac surgery during extracorporeal circulation period.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of changes in mean arterial pressure and bispectral index to changes in pupillary diameter	Compare changes in mean arterial pressure and bispectral index at the time of nociceptive stimulus with changes in pupillary diameter	During surgery / one day

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Fabien ESPITALIER, M.D, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2018
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Nociceptive stimulation
• Other Study ID Numbers: RIPH3-RNI18-DOLOCEC; 2018-A01137-48 (Other Identifier: IdRCB); 28/18_3 (Other Identifier: CPP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No