Clinical Trial: Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Pr Isabelle CONSTANT

Current Primary Outcome: 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


Original Primary Outcome: Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry [ Time Frame: 10 seconds after each stimulation. ]

Non-invasive measurement of pupillary diameter using an infrared camera.


Current Secondary Outcome: Heart rate variation [ Time Frame: 30 seconds after each stimulation ]

Original Secondary Outcome: Heart rate variation [ Time Frame: 20 seconds after each stimulation ]

Information By: Hôpital Armand Trousseau

Dates:
Date Received: January 4, 2016
Date Started: April 2012
Date Completion:
Last Updated: December 21, 2016
Last Verified: December 2016