NCT02648412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

9 months

First QC Date

January 4, 2016

Last Update Submit

December 21, 2016

Conditions

PainAnesthesia

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Heart rate variation

    30 seconds after each stimulation

Study Arms (1)

Ketamine sedation

EXPERIMENTAL

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: ketamineProcedure: Tetanic stimulations of incremental intensities

Interventions

ketamineDRUG

bolus 1 mg/kg

Ketamine sedation
Tetanic stimulations of incremental intensitiesPROCEDURE

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

Ketamine sedation

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Neurologic or ophthalmic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Isabelle Constant, PHD

    University Hospital Armand Trousseau

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 7, 2016

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

December 22, 2016

Record last verified: 2016-12

Locations

FR(1)