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

NCT ID: NCT02182648

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31

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.

Conditions

Bispectral Index; Pediatric; Etomidate; Induction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

etomidate group

infusion of etomidate at 2 minutes before anesthesia induction

Group Type: EXPERIMENTAL

etomidate

Intervention Type: DRUG

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

propofol group

infusion of propofol at 2 minutes before anesthesia induction

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

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

sevoflurane group

inhale sevoflurane for anesthesia induction and maintenance

Group Type: ACTIVE_COMPARATOR

sevoflurane

Intervention Type: DRUG

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

Interventions

etomidate

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

Intervention Type: DRUG

propofol

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

Intervention Type: DRUG

sevoflurane

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Enqiang Chang

Role: CONTACT

clinicaltriallh@163.com

Other Identifiers

etomidate children 20140625

Identifier Type: -

Identifier Source: org_study_id