Pupillometer as a Pain Index During General Anesthesia

Completed

• Conditions: Pupil; Anesthesia, General; Pain

• Registration Number: NCT04062864
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2019-08-18
• Study First Submitted QC: 2019-08-18
• Study First Posted: 2019-08-20
• Study Start: 2019-08-21
• Primary Completion: 2020-07-24
• Study Completion: 2020-07-24
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pupil diameter	From start of anesthesia to end of anesthesia	Pupil diameter before and after painful stimuli (skin incision, train-of-four stimulation)

Secondary Outcome Measures

Name	Time	Method
Bispectral index	From start of anesthesia to end of anesthesia	Bispectral index before and after painful stimuli (skin incision, train-of-four stimulation)
Pleth variability index	From start of anesthesia to end of anesthesia	Pleth variability index before and after painful stimuli (skin incision, train-of-four stimulation)

Trial Locations

Locations (1)

SNUH; 🇰🇷 Seoul, Jongno Gu, Korea, Republic of