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NCT02648412 Clinical Trial

Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02648412
Other study ID # Pupillo ketamine
Secondary ID
Status Completed
Phase N/A
First received January 4, 2016
Last updated December 21, 2016
Start date April 2012
Est. completion date April 2013

Study information
Verified date December 2016
Source Hôpital Armand Trousseau
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date April 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 18 Years
Eligibility 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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• ketamine
bolus 1 mg/kg
Procedure:
• Tetanic stimulations of incremental intensities
10-20-30-40-60 milliamps on the patient's left forearm

Locations
Country Name City State
France Departement d'anesthesie Hopital Armand Trousseau Paris

Sponsors (1)
Lead Sponsor Collaborator
Pr Isabelle CONSTANT

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry 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) No
Secondary Heart rate variation 30 seconds after each stimulation No
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