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

Zhengzhou University

Status and phase: Unknown; Phase 4

Conditions: Induction; Etomidate; Pediatric; Bispectral Index

Treatments: Drug: sevoflurane; Drug: propofol; Drug: etomidate

Study type: Interventional

Funder types: Other

Identifiers

NCT02182648

etomidate children 20140625

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

etomidate group

Experimental group

Description:

infusion of etomidate at 2 minutes before anesthesia induction

Treatment:

Drug: etomidate

propofol group

Active Comparator group

Description:

infusion of propofol at 2 minutes before anesthesia induction

Treatment:

Drug: propofol

sevoflurane group

Active Comparator group

Description:

inhale sevoflurane for anesthesia induction and maintenance

Treatment:

Drug: sevoflurane