DOLOCEC: Validation of Pupillary Response to Nociceptive Stimulation in Cardiac Surgery During Extracorporeal Circulation Period
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Other Outcome Measures
- Comparison of changes in mean arterial pressure and bispectral index to changes in pupillary diameter [During surgery / one day]
Compare changes in mean arterial pressure and bispectral index at the time of nociceptive stimulus with changes in pupillary diameter
Eligibility Criteria
Criteria
Inclusion Criteria:
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general anesthesia for cardiac surgery programmed requiring the realization of a sternotomy and the use of extra corporeal circulation
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age> 18 years
Exclusion Criteria:
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contraindication to the use of the products defined in the protocol of anesthesia (alprazolam, remifentanil, propofol, atracurium)
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sedation in progress with use of morphinomimetics
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urgent surgery
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preoperative existence of circulatory assistance
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preoperative existence of an intra-aortic balloon pump,
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bilateral ocular pathology (severe cataract, amblyopia, glaucoma, keratitis, conjunctivitis) and / or history of bilateral ocular surgery affecting the iris
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history of epilepsy, cerebral palsy
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peripheral neuromuscular diseases
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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
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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
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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
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pregnant or lactating women
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Patient having objected to the processing of his data
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Location Anesthesia-Resuscitation Department, University Hospital, Tours | Tours | France | 37044 |
Sponsors and Collaborators
- University Hospital, Tours
Investigators
- Principal Investigator: Fabien ESPITALIER, M.D, University Hospital, Tours
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RIPH3-RNI18-DOLOCEC
- 2018-A01137-48
- 28/18_3