Cognitive Changes in Childs After Anesthesia / Surgery

Withdrawn

• Conditions: Behavioral
• Interventions: Behavioral: anesthesia - surgery

• Registration Number: NCT02658526
• Lead Sponsor: Konstanze Plaschke

Brief Summary

The role of surgical stress and anesthesia is unknown in the early childhood. In vitro and animal studies showed a risk for treatment with anesthesia in the developmental brain. Furthermore, stress is also an important risk factor for cognitive impairment. Therefore, the investigators want to investigate in a clinical prospective cohort study the role anesthesia and surgery on different cognitive parameters and self-controling mechanisms in children under 3 years.

Detailed Description

In order to investigate the role of anesthesia and / or surgery on cognitive abilities the investigators want to perform a prospective cohort study in children under 3 years. Three groups should be compared: i) control without anesthesia / surgery, ii) children with only anesthesia, and iii) children with both surgery and anesthesia. All children will be investigate before and after intervention. Different behavioral scales will be used for detailed cognitive abilities and self-regulatory skills.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-20
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 9 month to 3 years with or without anesthesia / surgery

Exclusion Criteria

• Psychiatrical, neurological, oncological diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
surgery	anesthesia - surgery	children with anesthesia / surgery
anesthesia	anesthesia - surgery	children with anesthesia for diagnostic reason

Primary Outcome Measures

Name	Time	Method
Global cognitive abilities	4-6 weeks	Early Childhood Behavior Questionnaire (ECBQ) questionnaire

Secondary Outcome Measures

Name	Time	Method
surgery-associated data	1 day	Age (month)

Trial Locations

Locations (1)

University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School; 🇩🇪 Heidelberg, BW, Germany