Cognitive Changes in Childs After Anesthesia / Surgery

• Sponsor: Konstanze Plaschke (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02658526
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Behavioral	Behavioral: anesthesia - surgery

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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Role of Anesthesia / Surgery on Cognitive Function in Child
• Study Start Date: Dec 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
control children without anesthesia / surgery
anesthesia children with anesthesia for diagnostic reason	Behavioral: anesthesia - surgery
surgery children with anesthesia / surgery	Behavioral: anesthesia - surgery

Outcome Measures

Primary Outcome Measures

1. Global cognitive abilities [4-6 weeks]

   Bayley Scale

2. Global cognitive abilities [4-6 weeks]

   MONDEY (Milestone of Normal Development in Early Years) Scale

3. Global cognitive abilities [4-6 weeks]

   Assessment of temperament with the Infant Behavior Questionnaire Revised (IBQ-R) questionnaire

4. Global cognitive abilities [4-6 weeks]

   Early Childhood Behavior Questionnaire (ECBQ) questionnaire

Secondary Outcome Measures

1. surgery-associated data [1 - 3 days]

   reason of surgery

2. surgery-associated data [1 day]

   date of birth

3. surgery-associated data [1 day]

   length of surgery (h:min)

4. surgery-associated data [1 day]

   kind and quantity of anesthesia and medication (number)

5. surgery-associated data [1 day]

   Age (month)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Months to 3 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Psychiatrical, neurological, oncological diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School	Heidelberg	BW	Germany	69120

Sponsors and Collaborators

• Konstanze Plaschke

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Konstanze Plaschke, Prof., Heidelberg University
• ClinicalTrials.gov Identifier: NCT02658526
• Other Study ID Numbers: S-086/2014
• First Posted: Jan 20, 2016
• Last Update Posted: Apr 30, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Konstanze Plaschke, Prof., Heidelberg University: cognition; anesthesia; surgery; stress; child
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Apr 30, 2021