NCT03622242

Validity of Pain Threshold Index in Children

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Electroencephalography
• Anesthesia, General

Interventions

Type	Name	Description
DEVICE	Pain threshold index	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
DEVICE	Wavelet index	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

Timeline

• Start date: 2018-08-13
• Primary completion: 2019-06-30
• Completion: 2019-07-31
• First posted: 2018-08-09
• Last updated: 2018-08-16

Locations

1 site across 1 country: South Korea