Clinical trial NCT04062864: Pupillometer as a Pain Index During General Anesthesia
Official title: Validity of Pupil Diameter for Pain Monitoring During General Anesthesia in Children : a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Pupil
Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing surgery under general anesthesia at Seoul National University Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pupil diameter
timeFrame: From start of anesthesia to end of anesthesia
Secondary outcomes:
measure: Bispectral index
timeFrame: From start of anesthesia to end of anesthesia
measure: Pleth variability index
timeFrame: From start of anesthesia to end of anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongno Gu
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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