Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

NCT ID: NCT02648412

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Pain Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ketamine

Intervention Type DRUG

bolus 1 mg/kg

Tetanic stimulations of incremental intensities

Intervention Type PROCEDURE

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

Interventions

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ketamine

bolus 1 mg/kg

Intervention Type DRUG

Tetanic stimulations of incremental intensities

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pr Isabelle CONSTANT

OTHER

Sponsor Role lead

Responsible Party

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Pr Isabelle CONSTANT

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Isabelle Constant, PHD

Role: STUDY_DIRECTOR

University Hospital Armand Trousseau

Locations

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Departement d'anesthesie Hopital Armand Trousseau

Paris, , France

Site Status

Countries

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France

Other Identifiers

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Pupillo ketamine

Identifier Type: -

Identifier Source: org_study_id