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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01483313
Other study ID # RenJiH-20111005
Secondary ID
Status Withdrawn
Phase N/A
First received October 13, 2011
Last updated February 9, 2014
Start date November 2011
Est. completion date December 2012

Study information

Verified date March 2012
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2012
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria:

1. Born from 1995

2. Male

3. Parents or guardian agree to attend this study

4. Undergone minor surgery (Repair of hypospadias, phimosiectomy, cryptorchidectomy or cryptorchidopexy and repair of inguinal hernia)

5. Children who scarify the No.1 to No.3 but no experience of any surgery.

6. Those who undergone minor surgery in Renji Hospital 4-6years ago.

Exclusion Criteria:

1. Any congenital central nervous system diseases

2. Any congenital heart diseases

3. Any congenital dysgnosia

4. Birth weight less than 2kg

5. Ever been hypoxic encephalopathy when birth

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
China Renji Hospital Shanghai

Sponsors (2)

Lead Sponsor Collaborator
RenJi Hospital Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wechsler Intelligence Scale for Children Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery. Average 5 years after surgery No
Secondary Achenbach Child Behavior Checklist Wechsler Intelligence Scale for Children will be done after surgery, the expected average of 5 years after surgery. Average 5 years after surgery No
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