Clinical Study of Behavior Problems in Children After Different Anesthesia Methods
- Conditions
- Child BehaviorProblem Behavior
- Interventions
- Procedure: SevofluraneProcedure: TIVA
- Registration Number
- NCT02945072
- Lead Sponsor
- University Children's Hospital, Zurich
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sevoflurane group Sevoflurane general anesthesia will be maintained with sevoflurane TIVA group TIVA general anesthesia will be maintained with total intravenous anesthesia (propofol and remifentanyl)
- Primary Outcome Measures
Name Time Method Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively fourth week postoperative child's PHBQ score fourth week postoperatively
SDQ Questionnaire score postoperatively fourth week postoperative child's SDQ score fourth week postoperatively
- Secondary Outcome Measures
Name Time Method postoperative pain Level (by CHEOPS) in the first postoperative week (3 times a day) CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) were used to evaluate postoperative pain level
Intraoperative awareness in the first and second postoperative day In order to record an intraoperative awareness, a semistructured interview is conducted with test questions.
postoperative pain Level (by VAS) in the first postoperative week (3 times a day) Visual Analog Scale for Pain (VAS Pain) were used to evaluate postoperative pain level
postoperative pain medication in the first postoperative week All pain medications are recorded during the first postoperative week.Nurses and parents recorded all substance and application times by questionnaire.
postoperative Nausea and vomiting in the first and second postoperative day Nausea and Vomiting are recognized in frequency and time using a questionnaire.
Trial Locations
- Locations (1)
Dr. Philipp Buehler
🇨🇭Zurich, Switzerland