Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI

July 7, 2020 updated by: Pr Isabelle CONSTANT

Pupillary Diameter Variations in Response to Tetanic Stimulations of Incremental Intensities in Patients Under Propofol-remifentanil TCI

In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of incremental intensities were applied to the patients. Pupillary dilation in response to these stimulations was recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the study was to investigate a possible correlation between the intensity of a nociceptive stimulus and the magnitude of pupillary reflex dilation in patients anesthetized with propofol and remifentanil target-controlled infusion.

Anesthetic protocol: 10 minutes of steady-state general anesthesia (before extubation during a scheduled gynecological surgery) with remifentanil target concentration of 1 ng/ml, and propofol target concentration adjusted to maintain bispectral index between 45 and 55.

Study period: 6 tetanic stimulations of incremental intensities were applied to the patients: 10, 20, 30, 40, 50, 60 milliamps Pupillary dilation in response to these stimulations was recorded.

Then, propofol and remifentanil infusions were discontinued, and patients were extubated.

Study Type

Interventional

Enrollment (Actual)

18

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Scheduled gynecological surgery requiring general anesthesia and orotracheal intubation
  • written informed consent

Exclusion Criteria:

  • ophthalmic disease
  • neurologic disease
  • preoperative chronic pain or pain medication
  • medication interfering with autonomous nervous system (beta blockers, alpha agonists, metoclopramide, droperidol, atropine, catecholamines)

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: pupillometry
General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph
Procedure: general anesthesia for scheduled gynecological surgery
Drug: Propofol
continuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55
Drug: Remifentanil, Ultiva®
continuous infusion, target concentration 1 ng/ml
Procedure: tetanic stimulations
10-20-30-40-50-60 milliamps, 5 seconds, 100 Hertz 2 minutes between stimulations delivered via the standard neuromuscular blocking agents monitor
Device: VideoAlgesiGraph
non invasive infrared camera placed in front of the left eye of the patients during the study period, connected to a laptop. No part of the device touches the eye.
Other Names:
  • VideoAlgesiGraph, Synapsis (TM), Marseille, France

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pupillary diameter
Time Frame: 5 seconds before tetanic stimulation
as measured by VideoAlgesiGraph, in mm
5 seconds before tetanic stimulation
Pupillary diameter
Time Frame: 1 minute after tetanic stimulation
as measured by VideoAlgesiGraph, in mm
1 minute after tetanic stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 5 seconds before tetanic stimulation
as measured by the standard cardioscope
5 seconds before tetanic stimulation
Heart rate
Time Frame: 1 minute after tetanic stimulation
as measured by the standard cardioscope
1 minute after tetanic stimulation

Collaborators and Investigators

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

Sponsor

Pr Isabelle CONSTANT

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

January 1, 2012

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

July 7, 2020

First Posted (ACTUAL)

July 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pupillo propofol remi stim

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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