Validity of Pain Threshold Index in Children

Seoul National University

Status: Unknown

Conditions: Electroencephalography; Anesthesia, General

Treatments: Device: Wavelet index; Device: Pain threshold index

Study type: Interventional

Funder types: Other

Identifiers

NCT03622242

D-1804-059-936

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Pain threshold index group

Experimental group

Description:

Adjust infusion rate of remifentanil and propofol according to pain threshold index and wavelet index in 'pain threshold index group'.

Treatment:

Device: Pain threshold index

Device: Wavelet index

Control group

Active Comparator group

Description:

As conventional management, adjust infusion rate of remifentanil and propofol according to wavelet index and conventional vital signs

Treatment:

Device: Wavelet index