Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

December 21, 2016 updated by: Pr Isabelle CONSTANT

Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine sedation

Procedure scheduled under ketamine sedation. Baseline pupillary diameter measurement in alert subjects. Injection of a bolus of 1 mg/kg of ketamine. Every minute, tetanic stimulations of incremental intensities (10-20-30-40-60 milliamps), during 5 seconds.

Pupillary diameter measurement before and after each stimulation. End of study period, beginning of procedure.
Drug: ketamine
bolus 1 mg/kg
Procedure: Tetanic stimulations of incremental intensities
10-20-30-40-60 milliamps on the patient's left forearm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 seconds after each stimulation (6 stimulations per patient)

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate variation
Time Frame: 30 seconds after each stimulation
30 seconds after each stimulation

Collaborators and Investigators

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

Sponsor

Pr Isabelle CONSTANT

Investigators

  • Study Director: Isabelle Constant, PHD, University Hospital Armand Trousseau

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

April 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pupillo ketamine

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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