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Completed

NCT Number: NCT04465773

Pupillary Response to Incremental Tetanic Stimulations 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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

general anesthesia for scheduled gynecological surgery

Procedure

Propofol

Drug

continuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55

Remifentanil, Ultiva®

Drug

continuous infusion, target concentration 1 ng/ml

Tetanic stimulations

Procedure

10-20-30-40-50-60 milliamps, 5 seconds, 100 Hertz 2 minutes between stimulations delivered via the standard neuromuscular blocking agents monitor

VideoAlgesiGraph

Device

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

Primary outcomes

  1. Pupillary diameter

    Time frame: 5 seconds before tetanic stimulation

    as measured by VideoAlgesiGraph, in mm

  2. Pupillary diameter

    Time frame: 1 minute after tetanic stimulation

    as measured by VideoAlgesiGraph, in mm

Secondary outcomes

  1. Heart rate

    Time frame: 5 seconds before tetanic stimulation

    as measured by the standard cardioscope

  2. Heart rate

    Time frame: 1 minute after tetanic stimulation

    as measured by the standard cardioscope

Sponsors and collaborators

Lead sponsor

Pr Isabelle CONSTANT

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jul 10, 2020
Registry last updated
Jul 10, 2020

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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