The Effect of Propofol or Etomidate on Cognitive Function for 1-3 Years Old Children
Information source: Guilin Medical University, China
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia
Phase: N/A
Status: Recruiting
Sponsored by: Guilin Medical University, China Official(s) and/or principal investigator(s): Lei xun, MD, Study Director, Affiliation: Guilin Medical University, China
Overall contact: xun lei, MD, Phone: (86)0773-5895812, Email: leixun@glmc.edu.cn
Summary
Based on China's guangxi guilin for a hernia operation in 1 to 3 years old preschool
children propofol and etomidate on behavioral and cognitive function after intravenous
anesthesia in according to beta protein in serum and plasma glutamate (Glutamic acid, Glu)
and gamma-aminobutyric acid (Gamma aminobutyric acid, GABA) level of observation, the rapid
development period children's cognitive function after anesthesia short-term and long-term
change process and its possible mechanism is studied, for the current international debate
on "anesthetics effects on developing kids brain nerve" research hot spot in the city of
clinical basis and research argument, for pediatric anesthesia clinical safety, provide
theoretical basis for the rational use of drugs.
Clinical Details
Official title: the Study of Propofol or Etomidate Affecting to the Cognitive Function for 1-3 Years Old Children in the 7 Days and 3 Months.
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: The concentration of serum S100 β protein
Secondary outcome: Plasma levels of Glutamic acid(Glu) and Gamma-aminobutyric acid(GABA) concentration.
Detailed description:
1. by selecting the aged 1 to 3, 100 cases of patients with elective surgery, were
randomly divided into the propofol group (P group), the etomidate group (group E), all
the 50 cases, healthy age 50 cases of children (blank control group, group C) were
studied;
2. the children's intelligence equation of the People's Republic of China
neuropsychological test: P, E group of preoperative 1 day before operation,
postoperative day 3, 3 months neuropsychological test, observe and evaluate patients
POCD is happening; Correspond to the experimental group in the same period in group C,
i. e., the first test (1 d) preoperatively, 4 days after the second test (3 d) after
operation, 3 months after the third test (3 months), observed and compared with
experimental neuropsychological testing of variation;
3. laboratory of brain damage index determination: extract internal jugular venous blood
in preoperative and perioperative finish 5 ml, with double antibody immune sandwich
enzyme-linked immunosorbent (ELISA) method of determination of serum S - 100 beta
protein levels, rapid determination of amino acid analyzer, plasma Glu, GABA levels;
4. statistical analysis: use SPSS13. 0 statistical software for children with cognitive
function before and after operation and serum S - 100 beta protein and serum Glu, GABA
levels change research results should carry on the analysis of variance, P < 0. 05 for
statistical significance.
5. clear rapid development period of infants receive propofol and etomidate on plasma
according to beta protein after intravenous anesthesia and Glu, GABA expression and its
relationship between the change of cognitive function and clarify all according to
propofol and etomidate intravenous anesthesia on the brain is in rapid development
period of infant short-term and long-term postoperative cognitive function and its
possible mechanism, the influence of safety for children suffering from anesthesia, and
to provide theoretical basis for the rational use of drugs.
Eligibility
Minimum age: 1 Year.
Maximum age: 3 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Signed informed consent; elective laparoscopic hernia repair and appendectomy and
other non cardiac operation and Department of cerebral surgery; age 1-3; ASA grade
I~II;
Exclusion Criteria:
- Heart, lung, liver, kidney function was abnormal; she has a history of asthma,
central nervous system diseases, congenital disorders, hyperactivity, anesthesia
operation history; there are factors to evaluate any impact cognitive functions such
as language, severe visual and hearing impairment; expected before surgery in
patients with delayed extubation; any reason not to cooperate to complete the whole
test; perioperative bleeding again; postoperative anesthesia operation; operation
time >1h; extubation in patients with delayed; quit by researchers in the process of.
Locations and Contacts
xun lei, MD, Phone: (86)0773-5895812, Email: leixun@glmc.edu.cn
Guilin Medical University, Guilin, Guangxi 541004, China; Recruiting hong yi Jiang, MD, Phone: 013607736057, Email: jiangyihong6@163.com
Additional Information
Starting date: July 2014
Last updated: July 23, 2014
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