Validity of Pain Threshold Index in Children

Study Overview
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Brief Summary
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Comparison of total infused dose of remifentanil between pain threshold index monitoring group and control group

Detailed Description
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Investigators plan to enroll pediatric patients aged between 3 and 12 years old undergoing surgery under general anesthesia with continuous infusion of 2% propofol and remifentanil. After dividing them into two groups, investigators monitor pain threshold index and wavelet index in test group and adjust remifentanil infusion to maintain both indices in desirable range, while monitoring only wavelet index and adjust remifentanil infusion to maintain wavelet index and conventional vital signs in desirable range in control group. Investigators compare consumption of remifentanil, time to extubation after surgery, and post-anesthesia care unit length of stay between both groups.

Official Title
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Validity of Pain Threshold Index Based on Electroencephalogram for Pediatric Patients Under General Anesthesia

Conditions
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Electroencephalography, Anesthesia, General

Intervention / Treatment
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* Device: Pain threshold index
* Device: Wavelet index


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 3 and 12 years old undergoing orthopedic surgery at extremities under general anesthesia Exclusion Criteria: History of adverse drug reactions to opioids Underlying neurological disease or taking medication for neurologic purpose Patients who were transferred to intensive care unit after the surgery

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain threshold index group<br>Adjust infusion rate of remifentanil and propofol according to pain threshold index and wavelet index in 'pain threshold index group'. | Device: Pain threshold index<br>* In pain threshold index monitor, monitor patients' pain threshold index based on electroencephalography and adjust infusion rate of remifentanil and propofol according to pain threshold index<br>Device: Wavelet index<br>* In wavelet index monitor, monitor patients' wavelet index based on electroencephalography as an indicator of depth of anesthesia and adjust infusion rate of propofol according to wavelet index<br>|
| Active Comparator: Control group<br>As conventional management, adjust infusion rate of remifentanil and propofol according to wavelet index and conventional vital signs | Device: Wavelet index<br>* In wavelet index monitor, monitor patients' wavelet index based on electroencephalography as an indicator of depth of anesthesia and adjust infusion rate of propofol according to wavelet index<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remifentanil consumption | Total amount of infused remifentanil divided by patient's weight and total anesthesia time | At the end of anesthesia, total anesthesia time less than 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation time | Elapsed time from end of surgery to extubation | At the end of anesthesia, less than 1 hour | 
| Post-anesthesia care unit length of stay | Length of stay at post-anesthesia care unit | At discharge from post-anesthesia care unit, less than 1 day |