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

Information source: Henan Provincial Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bispectral Index; Pediatric; Etomidate; Induction

Intervention: etomidate (Drug); propofol (Drug); sevoflurane (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Henan Provincial Hospital

Overall contact:
Enqiang Chang, Email: clinicaltriallh@163.com

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.

Clinical Details

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

Primary outcome:

the amount of drugs

the drugs used time

numbers of muscular fibrillation

degree of inflammation reaction

adrenal function

Secondary outcome:

hemodynamic parameters

sedation degree

Eligibility

Minimum age: 3 Years. Maximum age: 10 Years. Gender(s): Both.

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

Locations and Contacts

Enqiang Chang, Email: clinicaltriallh@163.com

Additional Information

Starting date: October 2014
Last updated: July 2, 2014

Page last updated: August 23, 2015

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