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Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation

Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02648412
Enrollment
24
Registered
2016-01-07
Start date
2012-04-30
Completion date
2013-04-30
Last updated
2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Pain

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.

Interventions

DRUGketamine

bolus 1 mg/kg

PROCEDURETetanic stimulations of incremental intensities

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

Sponsors

Pr Isabelle CONSTANT
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry30 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

MeasureTime frame
Heart rate variation30 seconds after each stimulation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026