Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

Not Applicable

Completed

• Conditions: Anesthesia; Pain
• Interventions: Drug: ketamine; Procedure: Tetanic stimulations of incremental intensities

• Registration Number: NCT02648412
• Lead Sponsor: Pr Isabelle CONSTANT

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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Exclusion Criteria

• Neurologic or ophthalmic disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine sedation	ketamine	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.
Ketamine sedation	Tetanic stimulations of incremental intensities	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.

Primary Outcome Measures

Name	Time	Method
Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry	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 Outcome Measures

Name	Time	Method
Heart rate variation	30 seconds after each stimulation

Trial Locations

Locations (1)

Departement d'anesthesie Hopital Armand Trousseau; 🇫🇷 Paris, France