- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483313
Intelligence Changes Following Minor Surgery
February 9, 2014 updated by: diansan su, RenJi Hospital
Intelligence Performance in Adolescence After Early Exposure to Anesthesia and Minor Surgery
Animal studies showed that many general anesthetics might result in neuron apoptosis and neurocognitive impairment in the developing brain.
However results from human studies are conflicted.
In present study, the investigators examined the association between early exposure to anesthesia and surgery for minor surgery and intelligence changes in adolescence using the Wechsler Intelligence Scale for Children.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China, 200127
- Renji Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
The investigators would like chose the Children who undergone minor surgery in Renji hospital 4-6years ago and their friends who never had any surgery.
Description
Inclusion Criteria:
- Born from 1995
- Male
- Parents or guardian agree to attend this study
- Undergone minor surgery (Repair of hypospadias, phimosiectomy, cryptorchidectomy or cryptorchidopexy and repair of inguinal hernia)
- Children who scarify the No.1 to No.3 but no experience of any surgery.
- Those who undergone minor surgery in Renji Hospital 4-6years ago.
Exclusion Criteria:
- Any congenital central nervous system diseases
- Any congenital heart diseases
- Any congenital dysgnosia
- Birth weight less than 2kg
- Ever been hypoxic encephalopathy when birth
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wechsler Intelligence Scale for Children
Time Frame: Average 5 years after surgery
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Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery.
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Average 5 years after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Achenbach Child Behavior Checklist
Time Frame: Average 5 years after surgery
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Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery.
|
Average 5 years after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Diansan Su, M.D., Ph.D, Renji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Anticipated)
October 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
October 13, 2011
First Submitted That Met QC Criteria
November 29, 2011
First Posted (Estimate)
December 1, 2011
Study Record Updates
Last Update Posted (Estimate)
February 11, 2014
Last Update Submitted That Met QC Criteria
February 9, 2014
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RenJiH-20111005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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