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OpenTrials
Completed

NCT Number: NCT02595476

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

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Remifentanil

Drug

Propofol

Drug

TCI

Device

Tetanic stimulation

Procedure

Algiscan

Device

Pupillometry

Primary outcomes

  1. Post-stimulation Pupillary reflex dilation

    Time frame: 30 seconds

    percentage of dilation compared to pre-stimulation pupillary diameter

Sponsors and collaborators

Lead sponsor

Hôpital Armand Trousseau

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 3, 2015
Registry last updated
Apr 4, 2017

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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