NCT02182648

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

July 8, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

June 29, 2014

Last Update Submit

July 2, 2014

Conditions

Bispectral IndexPediatricEtomidateInduction

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • hemodynamic parameters

    from the beginning of induction to skin closure, up to 3 hours

  • sedation degree

    from the beginning of induction to skin closure, up to 3 hours

Study Arms (3)

etomidate group

EXPERIMENTAL

infusion of etomidate at 2 minutes before anesthesia induction

Drug: etomidate

propofol group

ACTIVE COMPARATOR

infusion of propofol at 2 minutes before anesthesia induction

Drug: propofol

sevoflurane group

ACTIVE COMPARATOR

inhale sevoflurane for anesthesia induction and maintenance

Drug: sevoflurane

Interventions

etomidateDRUG

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

etomidate group
propofolDRUG

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

propofol group
sevofluraneDRUG

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

sevoflurane group

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • obtain informed consent;
  • undergoing elective hypospadias repair surgery under general anesthesia;
  • American society of anesthesiologists (ASA) class I-II;
  • aged between 3-10 years old;
  • BMI is 18.5-30 kg/m2;

You may not qualify if:

  • systolic blood pressure≥180 mmHg or\<90 mmHg, diastolic blood pressure≥110 mmHg or\<60 mmHg;
  • serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
  • long-term use of hormone or a history of adrenal cortex inhibition;
  • suspected or confirmed difficult airway;
  • suspected or confirmed abuse of narcotic analgesic drugs, psychotropic drugs;
  • neuromuscular disease;
  • mental instability, or have a mental illness;
  • allergic to investigational products or with other contraindication
  • participated in other study within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

EtomidatePropofolSevoflurane

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Central Study Contacts

Enqiang Chang

CONTACT

clinicaltriallh@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2014

First Posted

July 8, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Last Updated

July 8, 2014

Record last verified: 2014-06