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Completed

NCT Number: NCT04062864

Pupillometer as a Pain Index During General Anesthesia

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

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Key information

Conditions

Anesthesia, General Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pupil Signs and Symptoms

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SNUH

Seoul, Jongno Gu, 15710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pupil size

Device

Measures the diameter of pupil before and after painful stimuli

Other names: Pupillometer

Primary outcomes

  1. Pupil diameter

    Time frame: From start of anesthesia to end of anesthesia

    Pupil diameter before and after painful stimuli (skin incision, train-of-four stimulation)

Secondary outcomes

  1. Bispectral index

    Time frame: From start of anesthesia to end of anesthesia

    Bispectral index before and after painful stimuli (skin incision, train-of-four stimulation)

  2. Pleth variability index

    Time frame: From start of anesthesia to end of anesthesia

    Pleth variability index before and after painful stimuli (skin incision, train-of-four stimulation)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 20, 2019
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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