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

Opioid Use Clinical Trial

— DOLOCEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568396
• Other study ID #: RIPH3-RNI18-DOLOCEC
• Secondary ID: 2018-A01137-4828
• Status: Completed
• Start date: August 22, 2018
• Est. completion date: October 25, 2018

Study information

• Verified date: February 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Location Anesthesia-Resuscitation Department, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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