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

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ClinicalTrials.gov Identifier: NCT02182648
Recruitment Status : Unknown
Verified June 2014 by Henan Provincial People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Henan Provincial People's Hospital

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.

Condition or disease Intervention/treatment Phase
Bispectral Index Pediatric Etomidate Induction Drug: etomidate Drug: propofol Drug: sevoflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2014
Estimated Primary Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: etomidate group
infusion of etomidate at 2 minutes before anesthesia induction
Drug: 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

Active Comparator: propofol group
infusion of propofol at 2 minutes before anesthesia induction
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

Active Comparator: sevoflurane group
inhale sevoflurane for anesthesia induction and maintenance
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




Primary Outcome Measures :
  1. the amount of drugs [ Time Frame: from the beginning of induction to Bispectral Index < 50,up to 5 minutes ]
    the amount of etomidate,propofol and sevoflurane used in anesthesia induction

  2. the drugs used time [ Time Frame: from the beginning of induction to Bispectral Index < 50,expected to be within 1 minute ]
    the injection time of etomidate and propofol, and the inhale time of sevoflurane during anesthesia induction

  3. numbers of muscular fibrillation [ Time Frame: from the beginning of induction to Bispectral Index < 50,up to 5 minutes ]
    numbers of muscular fibrillation in anesthesia induction

  4. degree of inflammation reaction [ Time Frame: baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation ]
    serum levels of interleukin 6 and tumor necrosis factor α will be measured at each time point using ELISA method

  5. adrenal function [ Time Frame: baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation ]
    serum level of cortisol will be measured at each time point using radioimmunoassay


Secondary Outcome Measures :
  1. hemodynamic parameters [ Time Frame: from the beginning of induction to skin closure, up to 3 hours ]
    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

  2. sedation degree [ Time Frame: from the beginning of induction to skin closure, up to 3 hours ]
    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



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182648


Contacts
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Contact: Enqiang Chang clinicaltriallh@163.com

Sponsors and Collaborators
Henan Provincial People's Hospital

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Responsible Party: Henan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT02182648    
Other Study ID Numbers: etomidate children 20140625
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Anesthetics
Propofol
Sevoflurane
Etomidate
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation