The Effect of Propofol or Etomidate on Cognitive Function for 1-3 Years Old Children

NCT02199990 | Unknown DMC

• 1 other identifier: 49850254-1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia

Keywords

cognitive function; propofol; etomidate;

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  One hour before anesthesia, one hour after the end of anesthesia.

Other Outcomes (1)

• The test results of neuropsychology

  One day before the operation, third days after the operation, third months after the operation

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guilin Medical University, China: lead

Study Sites (1)

Guilin Medical University

Guilin, Guangxi, 541004, China

RECRUITING

Study Officials

• Lei xun, MD

  Guilin Medical University, China

  STUDY DIRECTOR

Central Study Contacts

xun lei, MD

CONTACT

(86)0773-5895812; leixun@glmc.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, chief physician

Study Record Dates

• First Submitted: July 20, 2014
• First Posted: July 25, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

CN (1)