Clinical Study of Behavior Problems in Children After Different Anesthesia Methods

Study Overview
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Brief Summary
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The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA)

Detailed Description
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The process of surgery and anaesthesia can be an extremely frightening and stressful event for a child, and is frequently followed by negative postoperative behavioural changes. This Event could be associated with poor postoperative outcome and long term behavior problems like anxiety, eating or sleeping disorders. The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA). After anesthesia initiation, anesthesia maintenance should be done with sevoflurane or Tiva. The effect of behavioral changes in children in the context of anesthesia techniques should be evaluate by post hospitalisation behavior and Strengths and Difficulties Questionnaire at first, second and fourth week. Early postoperative problems like postoperative nausea and vomiting, pain level, pain therapy and postoperative awareness should be evaluate too.

Official Title
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Postoperative Behavior in Children: A Comparison of Inhalation Anesthesia (Sevoflurane) Versus Total Intravenous Anesthesia (TIVA)

Conditions
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Child Behavior, Problem Behavior

Intervention / Treatment
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* Procedure: TIVA
* Procedure: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective Operation operation in general anesthesia in combination with regional anesthesia Age 2-10 years ASA classification 1 or 2 (without severe basic disease or disability) Exclusion Criteria: Lack of Consensus general anesthesia during the last 3 months before or 4 weeks after the procedure PONV prophylaxis with droperidol severe known growth factor mental pre-existing conditions and behavioral abnormalities contraindications for one of the used study medications insufficient regional anesthesia secondary intervention within of the 4-week follow-up

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane group<br>general anesthesia will be maintained with sevoflurane | Procedure: Sevoflurane<br>* Sevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required)<br>|
| Experimental: TIVA group<br>general anesthesia will be maintained with total intravenous anesthesia (propofol and remifentanyl) | Procedure: TIVA<br>* TIVA is use to anesthesia maintenance after anesthesia induction (Propofol 10mg/kg/h, Remifentanil 0.2mcg/kg/min, dose adaptation as required for sufficient anesthesia)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively | child's PHBQ score first week postoperatively | first week postoperative | 
| Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively | child's PHBQ score second week postoperatively | second week postoperative | 
| Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively | child's PHBQ score fourth week postoperatively | fourth week postoperative | 
| SDQ Questionnaire score postoperatively | child's SDQ score first week postoperatively | first week postoperative | 
| SDQ Questionnaire score postoperatively | child's SDQ score second week postoperatively | second week postoperative | 
| SDQ Questionnaire score postoperatively | child's SDQ score fourth week postoperatively | fourth week postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain Level (by VAS) | Visual Analog Scale for Pain (VAS Pain) were used to evaluate postoperative pain level | in the first postoperative week (3 times a day) | 
| postoperative pain Level (by CHEOPS) | CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) were used to evaluate postoperative pain level | in the first postoperative week (3 times a day) | 
| postoperative pain medication | All pain medications are recorded during the first postoperative week.Nurses and parents recorded all substance and application times by questionnaire. | in the first postoperative week | 
| Intraoperative awareness | In order to record an intraoperative awareness, a semistructured interview is conducted with test questions. | in the first and second postoperative day | 
| postoperative Nausea and vomiting | Nausea and Vomiting are recognized in frequency and time using a questionnaire. | in the first and second postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child Behavior, Problem Behavior, postoperative behaviour problems