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

Completed

• Conditions: Analgesics; Opioid Use; Anesthetics, Intravenous; Monitoring, Intraoperative; Pupil; Dose-Response Relationship, Drug; Circulation, Extracorporeal; Electroencephalography/Drug Effects; Adult; Surgery, Cardiac
• Interventions: Device: Pupillometer

• Registration Number: NCT03568396
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-06-26
• Study Start: 2018-08-22
• Primary Completion: 2018-10-25
• Study Completion: 2018-10-25
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pupillometry	Pupillometer	The relationship between the target effect site concentration of remifentanil and the pupil diameter and reactivity in response to a standard noxious stimulus.

Primary Outcome Measures

Name	Time	Method
Validation the use of pupillometry as a method of evaluation of nociception in cardiac surgery during the extracorporeal circulation period.	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 Outcome Measures

Name	Time	Method
Validity of pupillometry nociception measurements in moderate hypothermia	During surgery / one day	To prove existence of a linear correlation between the change in pupillary diameter and the remifentanil concentration in moderate hypothermia.

Trial Locations

Locations (1)

Location Anesthesia-Resuscitation Department, University Hospital, Tours; 🇫🇷 Tours, France