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

July 22, 2016 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • UniversityHospitalGrenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Device: Measure the minimum intensity of a painful stimulation
With Neurolight device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of pupillary dilatation's reflex (RDP)
Time Frame: 13 seconds
Vidéopupillometer Neurolight®
13 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-François Payen, Professor, Grenoble Hospital University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC12.207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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