Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus

March 31, 2017 updated by: Pr Isabelle CONSTANT, Hôpital Armand Trousseau

The Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus Under Steady-state Remifentanil Analgesia

A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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
      • Paris, France, 75012
        • Departement d'anesthesie Hopital Armand Trousseau

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

10 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1-2
  • scheduled for an idiopathic scoliosis surgical correction

Exclusion Criteria:

  • Ophtalmologic pathology
  • Neurologic or muscular pathology
  • Metabolic pathology
  • Chronic pain

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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIS 55

  1. Induction:

    TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg)

  2. Orotracheal Intubation
  3. Remifentanil target decreased to 1 ng/ml
  4. Propofol target adjustment to reach BIS 55
  5. 10 minutes steady state
  6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds
  7. Pupillary dilation recording (videopupillometer Algiscan)
Drug: propofol
Drug: Remifentanil
Device: TCI
Procedure: Tetanic stimulation
Device: Algiscan
Pupillometry
Active Comparator: BIS 25

  1. Induction:

    TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg)

  2. Orotracheal Intubation
  3. Remifentanil target decreased to 1 ng/ml
  4. Propofol target adjustment to reach BIS 25
  5. 10 minutes steady state
  6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds
  7. Pupillary dilation recording (videopupillometer Algiscan)
Drug: propofol
Drug: Remifentanil
Device: TCI
Procedure: Tetanic stimulation
Device: Algiscan
Pupillometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-stimulation Pupillary reflex dilation
Time Frame: 30 seconds
percentage of dilation compared to pre-stimulation pupillary diameter
30 seconds

Collaborators and Investigators

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

Sponsor

Hôpital Armand Trousseau

Investigators

  • Study Director: Isabelle Constant, MD, PHD, Hôpital Armand Trousseau

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 (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 31, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anesthésie Trousseau 002

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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