Validity of Pain Threshold Index in Children

August 14, 2018 updated by: Hee-Soo Kim, Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Young-Eun Jang, M.D., M.S.
  • Phone Number: +82-10-9487-2233
  • Email: na0ag2@hotmail.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain threshold index group
Adjust infusion rate of remifentanil and propofol according to pain threshold index and wavelet index in 'pain threshold index group'.
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
Active Comparator: Control group
As conventional management, adjust infusion rate of remifentanil and propofol according to wavelet index and conventional vital signs
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remifentanil consumption
Time Frame: 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
At the end of anesthesia, total anesthesia time less than 1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee-Soo Kim, M.D., Ph.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

July 31, 2019

Study Registration Dates

First Submitted

July 8, 2018

First Submitted That Met QC Criteria

August 4, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • D-1804-059-936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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