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Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

Sponsor
Pr Isabelle CONSTANT (Other)
Overall Status
Completed
CT.gov ID
NCT02648412
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
12
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ketamine
  • Procedure: Tetanic stimulations of incremental intensities
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Heart rate variation [30 seconds after each stimulation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Departement d'anesthesie Hopital Armand Trousseau Paris France 75012

Sponsors and Collaborators

  • Pr Isabelle CONSTANT

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pr Isabelle CONSTANT, Professor, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier:
NCT02648412
Other Study ID Numbers:
  • Pupillo ketamine
First Posted:
Jan 7, 2016
Last Update Posted:
Dec 22, 2016
Last Verified:
Dec 1, 2016
Additional relevant MeSH terms:
Ketamine

Study Results

No Results Posted as of Dec 22, 2016