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

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.

Study Overview

• Status: Unknown
• Conditions: Pediatric; Bispectral Index; Induction; Etomidate
• Intervention / Treatment: Drug: etomidate; Drug: propofol; Drug: sevoflurane

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Enqiang Chang; Email: clinicaltriallh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: etomidate group; infusion of etomidate at 2 minutes before anesthesia induction	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
Active Comparator: propofol group; infusion of propofol at 2 minutes before anesthesia induction	Drug: 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
Active Comparator: sevoflurane group; inhale sevoflurane for anesthesia induction and maintenance	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
numbers of muscular fibrillation	numbers of muscular fibrillation in anesthesia induction	from the beginning of induction to Bispectral Index < 50,up to 5 minutes
degree of inflammation reaction	serum levels of interleukin 6 and tumor necrosis factor α 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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: June 29, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 2, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane; Etomidate
• Other Study ID Numbers: etomidate children 20140625