Bispectral Index, Etomidate, Induction, Pediatric
Conditions
Brief summary
This research through using bispectral index to guide the induced dose and speed of etomidate lipid emulsion for pediatric total venous anesthesia,and to provide a reference for clinical anesthesia physician.
Interventions
DRUGetomidate
1. intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. 2. infusion of etomidate at 2 minutes before anesthesia induction
DRUGpropofol
1. intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. 2. infusion of propofol at 2 minutes before anesthesia induction
DRUGsevoflurane
1. intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. 2. inhale sevoflurane for anesthesia induction and maintenance
Sponsors
Henan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
1. obtain informed consent; 2. undergoing elective hypospadias repair surgery under general anesthesia; 3. American society of anesthesiologists (ASA) class I-II; 4. aged between 3-10 years old; 5. BMI is 18.5-30 kg/m2;
Exclusion criteria
1. systolic blood pressure≥180 mmHg or\<90 mmHg, diastolic blood pressure≥110 mmHg or\<60 mmHg; 2. serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections; 3. long-term use of hormone or a history of adrenal cortex inhibition; 4. suspected or confirmed difficult airway; 5. suspected or confirmed abuse of narcotic analgesic drugs, psychotropic drugs; 6. neuromuscular disease; 7. mental instability, or have a mental illness; 8. allergic to investigational products or with other contraindication 9. participated in other study within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the drugs used time | from the beginning of induction to Bispectral Index < 50,expected to be within 1 minute | the injection time of etomidate and propofol, and the inhale time of sevoflurane during anesthesia induction |
| degree of inflammation reaction | baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation | serum levels of interleukin 6 and tumor necrosis factor α will be measured at each time point using ELISA method |
| adrenal function | baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation | serum level of cortisol will be measured at each time point using radioimmunoassay |
| the amount of drugs | from the beginning of induction to Bispectral Index < 50,up to 5 minutes | the amount of etomidate,propofol and sevoflurane used in anesthesia induction |
| numbers of muscular fibrillation | from the beginning of induction to Bispectral Index < 50,up to 5 minutes | numbers of muscular fibrillation in anesthesia induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sedation degree | from the beginning of induction to skin closure, up to 3 hours | Bispectral index,train-of-four stimulation and the temperature recorded at 4 time points including before anesthesia induction,before endotracheal intubation,after endotracheal intubation and after operation immediately |
| hemodynamic parameters | from the beginning of induction to skin closure, up to 3 hours | heart rate,blood pressure,electrocardiogram and pulse oxygen saturation recorded at 4 time points including before anesthesia induction,before endotracheal intubation,after endotracheal intubation and after operation immediately |
Contacts
Primary ContactEnqiang Chang
Outcome results
None listed