The External Validation of Pharmacokinetic-Pharmacodynamic Model of Propofol in Children under the age of 2

The External Validation of Pharmacokinetic-Pharmacodynamic Model of Propofol for Target-controlled Infusion in Children under the age of 2

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001752

Enrollment

Registered

2016-01-04

Start date

2016-02-16

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Target controlled infusion of propofol is performed using PK-PD model (kim&#39

s model) installed in Asan pump during general anesthesia in children &lt

2 yrs old. Monitoring of electrocardiogram, blood pressure, peripheral oxygen saturation and bispectral index (BIS) are performed during general anesthesia. Propofol target concentration is maintained

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Pediatric patients aged between 1 month and 2 years old, who are scheduled for neurosurgery or orthopedic surgery under general anesthesia ? Pediatri patients who need total intravenous anesthesia for neurophysiologic monitoring or risk of malignant hyperthermia

Exclusion criteria

Exclusion criteria: ? History of allergy or hypersensitivity to any medications ? Current use of patient controlled- analgesia including opioids ? Any cardiovascular disease or hypovolemia ? Bradycardia or hypotension ? Any severe lung, liver, kidney disease ? When invasive arterial blood pressure monitoring is not required ? Current hemodialysis ? BMI >35 ? Allergy to bean or soy bean

Design outcomes

Primary

Measure	Time frame
plasma concentration of propofol	—

Secondary

Measure	Time frame
Bispectral index	—

Countries

Korea, Republic of

Contacts

Public ContactHee-Soo kim

Seoul National University Hospital

heejeong895@gmail.com

Outcome results