Anesthesia, General, Electroencephalography
Conditions
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.
Interventions
DEVICEPain 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
DEVICEWavelet 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
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactSang-Hwan Ji, M.D., M.S.
Backup ContactYoung-Eun Jang, M.D., M.S.
Outcome results
None listed