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Completed

NCT Number: NCT02648412

Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

The aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation.

After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured before and after each stimulation.

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Key information

Conditions

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

Age range

2 year–18 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

  • Patient admitted to pediatric burns care unit
  • Burnt skin area 5-40%
  • Scheduled for a dressing change under ketamine sedation

Exclusion criteria

  • Neurologic or ophthalmic disease

Treatment and study plan

ketamine

Drug

bolus 1 mg/kg

Tetanic stimulations of incremental intensities

Procedure

10-20-30-40-60 milliamps on the patient's left forearm

Primary outcomes

  1. Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry

    Time frame: 30 seconds after each stimulation (6 stimulations per patient)

    Non-invasive measurement of pupillary diameter using an infrared camera, for each of the 6 stimulations per patient

Secondary outcomes

  1. Heart rate variation

    Time frame: 30 seconds after each stimulation

Sponsors and collaborators

Lead sponsor

Pr Isabelle CONSTANT

Other

Registry information

Official study title

Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2016
Registry last updated
Dec 22, 2016

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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