Validity of Pain Threshold Index in Children

Not Applicable

• Conditions: Electroencephalography; Anesthesia, General
• Interventions: Device: Pain threshold index; Device: Wavelet index

• Registration Number: NCT03622242
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Comparison of total infused dose of remifentanil between pain threshold index monitoring group and control group

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-07-08
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-04
• Study First Posted: 2018-08-09
• Study Start: 2018-08-13
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain threshold index group	Pain threshold index	Adjust infusion rate of remifentanil and propofol according to pain threshold index and wavelet index in 'pain threshold index group'.
Pain threshold index group	Wavelet index	Adjust infusion rate of remifentanil and propofol according to pain threshold index and wavelet index in 'pain threshold index group'.
Control group	Wavelet index	As conventional management, adjust infusion rate of remifentanil and propofol according to wavelet index and conventional vital signs

Primary Outcome Measures

Name	Time	Method
Remifentanil consumption	At the end of anesthesia, total anesthesia time less than 1 day	Total amount of infused remifentanil divided by patient's weight and total anesthesia time

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of