Skip to content

Pupillometer as a Pain Index During General Anesthesia

Validity of Pupil Diameter for Pain Monitoring During General Anesthesia in Children : a Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04062864
Enrollment
35
Registered
2019-08-20
Start date
2019-08-21
Completion date
2020-07-24
Last updated
2020-08-13

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

Conditions

Anesthesia, General, Pain, Pupil

Brief summary

This study evaluates the validity of pupil diameter as an indicator of pain during surgery under general anesthesia.

Detailed description

Pupil diameter is known to be strongly correlated with sympathetic tone. During surgery under general anesthesia, there is no standardized means of pain assessment. As pain activates sympathetic nervous system, we hypothesized that pupil diameter can be a marker for pain during surgery.

Interventions

DEVICEPupil size

Measures the diameter of pupil before and after painful stimuli

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Children undergoing surgery under general anesthesia with total time of less than two hours

Exclusion criteria

* Children whose parent or legal guardian declined to enroll * Any use of opioids during surgery * History of hypersensitivity to any anesthetic agents * Any medication that can affect sympathetic nervous activity * Presence of underlying ophthalmologic disease

Design outcomes

Primary

MeasureTime frameDescription
Pupil diameterFrom start of anesthesia to end of anesthesiaPupil diameter before and after painful stimuli (skin incision, train-of-four stimulation)

Secondary

MeasureTime frameDescription
Bispectral indexFrom start of anesthesia to end of anesthesiaBispectral index before and after painful stimuli (skin incision, train-of-four stimulation)
Pleth variability indexFrom start of anesthesia to end of anesthesiaPleth variability index before and after painful stimuli (skin incision, train-of-four stimulation)

Countries

South Korea

Outcome results

None listed

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