Evaluation of Pupillary Distension Reflexes, as a Tool for the Monitoring of Analgesia for Patients in Intensive Care.

Sedation-analgesia is an important therapy for patients in resuscitation. It requires a surveillance, in order to avoid excessive or insufficient dosages of sedative or nonmorphinics, sources of side effects. Yet, means of surveillance are limited in resuscitation care : variations of blood pressure and heart rate are not very sensitive criterias. Clinical scales to measure the sedation and analgesia level were proposed for patients in resuscitation, including the Richmond (RASS) sedation scale and the behavioural pain scale (BPS). The study of pupillary dilatation's reflex (RDP) due to a nociceptive stimulation is a tool proposed for the monitoring of the analgesia peroperative for patients under general anaesthetic. Yet, there isn't any study that measured the analgesia threshold by pupillometry for patients in resuscitation receiving a sedation-analgesia.

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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Key information

Conditions

Failure of Respiratory Function Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospitalGrenoble

La Tronche, 38700, France

About this study

Secondary goals will be to bring this measures back to the pain score BPS and the pupillary diameter measured during a painful care (tracheal aspiration), as well as morphinics dosage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Both gender
Adult over 18 years

Exclusion criteria

Neuromuscular pathology that does not allow the use of clinical scales in order to measure sedation-analgesia : tetraplegia, resuscitation neuromyopathy, curares.
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

Treatment and study plan

Measure the minimum intensity of a painful stimulation

Device

With Neurolight device.

Primary outcomes

Measure of pupillary dilatation's reflex (RDP)

Time frame: 13 seconds

Vidéopupillometer Neurolight®

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: PUPILLO REA

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jul 26, 2016
Registry last updated: Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed