Bispectral Index Guiding Etomidate Used in Children Aged 3 to 10 for Clinical Anesthesia Induction

Phase 4

• Conditions: Bispectral Index; Pediatric; Etomidate; Induction
• Interventions: Drug: etomidate; Drug: propofol; Drug: sevoflurane

• Registration Number: NCT02182648
• Lead Sponsor: Henan Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-29
• Study First Submitted QC: 2014-07-02
• Last Update Submitted: 2014-07-02
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08
• Study Start: 2014-10
• Primary Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
etomidate group	etomidate	infusion of etomidate at 2 minutes before anesthesia induction
propofol group	propofol	infusion of propofol at 2 minutes before anesthesia induction
sevoflurane group	sevoflurane	inhale sevoflurane for anesthesia induction and maintenance

Primary Outcome Measures

Name	Time	Method
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
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
numbers of muscular fibrillation	from the beginning of induction to Bispectral Index < 50,up to 5 minutes	numbers of muscular fibrillation in 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

Secondary Outcome Measures

Name	Time	Method
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
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