AnesthesiaNCT02199990
The Effect of Propofol or Etomidate on Cognitive Function for 1-3 Years Old Children
An observational study of Anesthesia, run by Guilin Medical University, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jul 2015
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 1.Guilin 1-3 years due to hernia surgery to receive propofol or etomidate total intravenous anesthesia in children. 2.1-3 years old healthy children in 4 kindergartens of different level of teachers in the Guilin city.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guilin Medical University
Guilin, Guangxi, 541004
hong yi Jiang, MD, 013607736057, jiangyihong6@163.com
About this study
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.
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.
Read the detailed description
- 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;
- 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;
- 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;
- 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.
- 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.
- Conditions
- Anesthesia
- Keywords
- cognitive function; propofol; etomidate;
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of serum S100 β protein
Respectively one hour before anesthesia, anesthesia for one hour 5 ml of blood from the jugular vein, serum S100β protein concentration.
Measured: One hour before anesthesia, one hour after the end of anesthesia.
Secondary outcomes (1)
Plasma levels of Glutamic acid（Glu) and Gamma-aminobutyric acid（GABA) concentration.
Respectively one hour before anesthesia, one hour after the end of anesthesia 5 ml of blood from the jugular vein, , plasma Glu, GABA concentration.
Measured: One hour before anesthesia, one hour after the end of anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Guilin Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hong yi Jiang,MD, Guilin Medical University, China
- Investigators
- Lei xun, MD, Study director, Guilin Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199990
- Sponsor's protocol ID
- 49850254-1
- Status last verified
- Jul 2014
- First submitted
- 20 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02199990
- Acronym / sponsor ID
- 49850254-1
- Conditions
- Anesthesia
- Keywords
- cognitive function; propofol; etomidate;
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guilin Medical University, ChinaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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;
- 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;
- 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;
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1.Guilin 1-3 years due to hernia surgery to receive propofol or etomidate total intravenous anesthesia in children. 2.1-3 years old healthy children in 4 kindergartens of different level of teachers in the Guilin city.
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The concentration of serum S100 β protein
Time frame: One hour before anesthesia, one hour after the end of anesthesia.
Respectively one hour before anesthesia, anesthesia for one hour 5 ml of blood from the jugular vein, serum S100β protein concentration.
1 secondary outcome
Plasma levels of Glutamic acid（Glu) and Gamma-aminobutyric acid（GABA) concentration.
Time frame: One hour before anesthesia, one hour after the end of anesthesia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei xun, MD study director
Guilin Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Guilin Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xun lei, MD ((86)0773-5895812, leixun@glmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of serum S100 β protein (time frame: One hour before anesthesia, one hour after the end of anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.