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Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

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ClinicalTrials.gov Identifier: NCT02648412
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Pr Isabelle CONSTANT, Hôpital Armand Trousseau

Tracking Information
First Submitted Date  ICMJE January 4, 2016
First Posted Date  ICMJE January 7, 2016
Last Update Posted Date December 22, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry [ Time Frame: 10 seconds after each stimulation. ]
Non-invasive measurement of pupillary diameter using an infrared camera.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
Heart rate variation [ Time Frame: 30 seconds after each stimulation ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
Heart rate variation [ Time Frame: 20 seconds after each stimulation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation
Official Title  ICMJE Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pain
  • Anesthesia
Intervention  ICMJE
  • Drug: ketamine
    bolus 1 mg/kg
  • Procedure: Tetanic stimulations of incremental intensities
    10-20-30-40-60 milliamps on the patient's left forearm
Study Arms  ICMJE 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.

Interventions:
  • Drug: ketamine
  • Procedure: Tetanic stimulations of incremental intensities
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2016)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02648412
Other Study ID Numbers  ICMJE Pupillo ketamine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pr Isabelle CONSTANT, Hôpital Armand Trousseau
Study Sponsor  ICMJE Pr Isabelle CONSTANT
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Isabelle Constant, PHD University Hospital Armand Trousseau
PRS Account Hôpital Armand Trousseau
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP