Postoperative Behavior in Children: A Comparison of Inhalation Anesthesia (Sevoflurane) Versus Total Intravenous Anesthesia (TIVA)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Child Behavior
- Sponsor
- University Children's Hospital, Zurich
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Time Frame: fourth week postoperative
child's PHBQ score fourth week postoperatively
SDQ Questionnaire score postoperatively
Time Frame: fourth week postoperative
child's SDQ score fourth week postoperatively
Secondary Outcomes
- postoperative pain Level (by CHEOPS)(in the first postoperative week (3 times a day))
- Intraoperative awareness(in the first and second postoperative day)
- postoperative pain Level (by VAS)(in the first postoperative week (3 times a day))
- postoperative pain medication(in the first postoperative week)
- postoperative Nausea and vomiting(in the first and second postoperative day)