A Phase 4 interventional study of TIVA and Sevoflurane in Child Behavior and Problem Behavior, sponsored by University Children's Hospital, Zurich. Completed at 1 site in Switzerland. Open to participants aged 2 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by University Children's Hospital, Zurich · Phase 4, Interventional, and Screening
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)
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.
517 studies on the registry are indexed under Problem Behavior; 92 are open to participants now.
This study's enrollment of 500 is above the median of 90 across 391 interventional studies indexed under Problem Behavior.
Browse Problem Behavior studies →University Children's Hospital, Zurich is the lead sponsor of 92 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
general anesthesia will be maintained with sevoflurane
Procedure: Sevoflurane
general anesthesia will be maintained with total intravenous anesthesia (propofol and remifentanyl)
Procedure: TIVA
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)
Sevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required)
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score first week postoperatively
Time frame: first week postoperative
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score second week postoperatively
Time frame: second week postoperative
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score fourth week postoperatively
Time frame: fourth week postoperative
SDQ Questionnaire score postoperatively
child's SDQ score first week postoperatively
Time frame: first week postoperative
SDQ Questionnaire score postoperatively
child's SDQ score second week postoperatively
Time frame: second week postoperative
SDQ Questionnaire score postoperatively
child's SDQ score fourth week postoperatively
Time frame: fourth week postoperative
postoperative pain Level (by VAS)
Visual Analog Scale for Pain (VAS Pain) were used to evaluate postoperative pain level
Time frame: 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
Time frame: 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.
Time frame: in the first postoperative week
Intraoperative awareness
In order to record an intraoperative awareness, a semistructured interview is conducted with test questions.
Time frame: in the first and second postoperative day
postoperative Nausea and vomiting
Nausea and Vomiting are recognized in frequency and time using a questionnaire.
Time frame: in the first and second postoperative day
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University Children's Hospital, Zurich