Evaluation of Pupillary Distension Reflexes, as a Tool for the Monitoring of Analgesia for Patients in Intensive Care.
NCT ID: NCT02843893
Last Updated: 2016-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2012-04-30
2015-03-31
Brief Summary
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The main goal of this study is to measure the minimum intensity of a painful stimulation (tetanus), leading to a 10% raise of RDP in a cohort of patients in resuscitation care receiving sedation-analgesia continuously.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Intubated and Mechanically Ventilated Patients
Intubated and Mechanically Ventilated Patients receiving by continuous intravenous an hypnotic sedation (midazolam or propofol) associate with a morphine type drug (fentanyl, sufentanil, rémifentanil, or morphine) since at least 6 hours and for a predictable duration over 24 hours.
Measure the minimum intensity of a painful stimulation
With Neurolight device.
Interventions
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Measure the minimum intensity of a painful stimulation
With Neurolight device.
Eligibility Criteria
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Inclusion Criteria
* Both gender
* Adult over 18 years
Exclusion Criteria
* Intracranial hypertension (intracranial pressure over 20 mmHg) whatever the cause (traumatique, vasculaire, tumorale).
* Dysautonomia altering the pupillary dilatation's reflex (RDP) : old diabetes with diabetic retinopathy, multiple sclerosis, systemic amylose.
* Treatment in progress which may affect the pupillary dilatation's reflex (RDP) : antiemetic (droperidol, métoclopramide), alpha-2 agoniste (clonidine).
* Ocular pathology
* Opiate addiction
* Refusal by a patient
* Pregnant women
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean-François Payen, Professor
Role: PRINCIPAL_INVESTIGATOR
Grenoble Hospital University
Locations
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UniversityHospitalGrenoble
La Tronche, , France
Countries
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References
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Sauder P, Andreoletti M, Cambonie G, Capellier G, Feissel M, Gall O, Goldran-Toledano D, Kierzek G, Mateo J, Mentec H, Mion G, Rigaud JP, Seguin P. [Sedation and analgesia in intensive care (with the exception of new-born babies). French Society of Anesthesia and Resuscitation. French-speaking Resuscitation Society]. Ann Fr Anesth Reanim. 2008 Jul-Aug;27(7-8):541-51. doi: 10.1016/j.annfar.2008.04.021. Epub 2008 Jun 24. No abstract available. French.
Carrion MI, Ayuso D, Marcos M, Paz Robles M, de la Cal MA, Alia I, Esteban A. Accidental removal of endotracheal and nasogastric tubes and intravascular catheters. Crit Care Med. 2000 Jan;28(1):63-6. doi: 10.1097/00003246-200001000-00010.
Lorente L, Huidobro MS, Martin MM, Jimenez A, Mora ML. Accidental catheter removal in critically ill patients: a prospective and observational study. Crit Care. 2004 Aug;8(4):R229-33. doi: 10.1186/cc2874. Epub 2004 Jun 2.
The management of the agitated ICU patient. Crit Care Med. 2002 Jan;30(1 Suppl Management):S97-123; quiz S124-25. No abstract available.
Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8. doi: 10.1378/chest.114.2.541.
Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
Chanques G, Jaber S, Barbotte E, Verdier R, Henriette K, Lefrant JY, Eledjam JJ. [Validation of the french translated Richmond vigilance-agitation scale]. Ann Fr Anesth Reanim. 2006 Jul;25(7):696-701. doi: 10.1016/j.annfar.2006.02.017. Epub 2006 May 15. French.
Puntillo KA, Morris AB, Thompson CL, Stanik-Hutt J, White CA, Wild LR. Pain behaviors observed during six common procedures: results from Thunder Project II. Crit Care Med. 2004 Feb;32(2):421-7. doi: 10.1097/01.CCM.0000108875.35298.D2.
Payen JF, Bru O, Bosson JL, Lagrasta A, Novel E, Deschaux I, Lavagne P, Jacquot C. Assessing pain in critically ill sedated patients by using a behavioral pain scale. Crit Care Med. 2001 Dec;29(12):2258-63. doi: 10.1097/00003246-200112000-00004.
Yang LL, Niemann CU, Larson MD. Mechanism of pupillary reflex dilation in awake volunteers and in organ donors. Anesthesiology. 2003 Dec;99(6):1281-6. doi: 10.1097/00000542-200312000-00008.
Barvais L, Engelman E, Eba JM, Coussaert E, Cantraine F, Kenny GN. Effect site concentrations of remifentanil and pupil response to noxious stimulation. Br J Anaesth. 2003 Sep;91(3):347-52. doi: 10.1093/bja/aeg178.
Constant I, Nghe MC, Boudet L, Berniere J, Schrayer S, Seeman R, Murat I. Reflex pupillary dilatation in response to skin incision and alfentanil in children anaesthetized with sevoflurane: a more sensitive measure of noxious stimulation than the commonly used variables. Br J Anaesth. 2006 May;96(5):614-9. doi: 10.1093/bja/ael073. Epub 2006 Mar 24.
Larson MD, Sessler DI, Washington DE, Merrifield BR, Hynson JA, McGuire J. Pupillary response to noxious stimulation during isoflurane and propofol anesthesia. Anesth Analg. 1993 May;76(5):1072-8. doi: 10.1213/00000539-199305000-00028.
Jeanne M, Joulin O. [The 18th meeting of the Societe Francophone d'Informatique et de Monitorage en Anesthesie-Reanimation (Sfimar)]. Ann Fr Anesth Reanim. 2011 Oct;30(10):770-1. doi: 10.1016/j.annfar.2011.08.007. Epub 2011 Sep 23. No abstract available. French.
Larson MD, Talke PO. Effect of dexmedetomidine, an alpha2-adrenoceptor agonist, on human pupillary reflexes during general anaesthesia. Br J Clin Pharmacol. 2001 Jan;51(1):27-33. doi: 10.1046/j.1365-2125.2001.01311.x.
Li D, Miaskowski C, Burkhardt D, Puntillo K. Evaluations of physiologic reactivity and reflexive behaviors during noxious procedures in sedated critically ill patients. J Crit Care. 2009 Sep;24(3):472.e9-13. doi: 10.1016/j.jcrc.2008.07.005. Epub 2009 Jan 17.
Other Identifiers
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38RC12.207
Identifier Type: -
Identifier Source: org_study_id
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