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

Pediatric Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02182648
• Other study ID #: etomidate children 20140625
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 29, 2014
• Last updated: July 2, 2014
• Start date: October 2014

Study information

• Verified date: June 2014
• Source: Henan Provincial Hospital
• Contact: Enqiang Chang
• Email: clinicaltriallh[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bispectral Index
• Etomidate
• Induction
• Pediatric

Intervention

Drug:
• etomidate
intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. infusion of etomidate at 2 minutes before anesthesia induction
• propofol
intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. infusion of propofol at 2 minutes before anesthesia induction
• sevoflurane
intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia. inhale sevoflurane for anesthesia induction and maintenance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the amount of drugs	the amount of etomidate,propofol and sevoflurane used in anesthesia induction	from the beginning of induction to Bispectral Index < 50,up to 5 minutes	No
Primary	the drugs used time	the injection time of etomidate and propofol, and the inhale time of sevoflurane during anesthesia induction	from the beginning of induction to Bispectral Index < 50,expected to be within 1 minute	No
Primary	numbers of muscular fibrillation	numbers of muscular fibrillation in anesthesia induction	from the beginning of induction to Bispectral Index < 50,up to 5 minutes	Yes
Primary	degree of inflammation reaction	serum levels of interleukin 6 and tumor necrosis factor a will be measured at each time point using ELISA method	baseline,5 minutes after indution,5 minutes before operation end,30 mimutes?24h and 48h after operation	Yes
Primary	adrenal function	serum level of cortisol will be measured at each time point using radioimmunoassay	baseline,5 minutes after indution,5 minutes before operation end,30 mimutes?24h and 48h after operation	Yes
Secondary	hemodynamic parameters	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	from the beginning of induction to skin closure, up to 3 hours	No
Secondary	sedation degree	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	from the beginning of induction to skin closure, up to 3 hours	No