Clinical Trial: Clinical Study of Behavior Problems in Children After Different Anesthesia Methods

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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 questionaire 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.
Sponsor: University Children's Hospital, Zurich

Current Primary Outcome:

• Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively [ Time Frame: first week postoperative ]
  child's PHBQ score first week postoperatively
• Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively [ Time Frame: second week postoperative ]
  child's PHBQ score second week postoperatively
• 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: first week postoperative ]
  child's SDQ score first week postoperatively
• SDQ Questionnaire score postoperatively [ Time Frame: second week postoperative ]
  child's SDQ score second week postoperatively
• SDQ Questionnaire score postoperatively [ Time Frame: fourth week postoperative ]
  child's SDQ score fourth week postoperatively

Original Primary Outcome:

• Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively [ Time Frame: first week postoperative ]
  child's PHBQ score first week postoperatively
• Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively [ Time Frame: second week postoperative ]
  child's PHBQ score second week postoperatively
• Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively [ Time Frame: fourth week postoperative ]
  d's PHBQ score fourth week postoperatively
• SDQ Questionnaire score postoperatively [ Time Frame: first week postoperative ]
  child's SDQ score first week postoperatively
• SDQ Questionnaire score postoperatively [ Time Frame: second week postoperative ]
  child's SDQ score second week postoperatively
• SDQ Questionnaire score postoperatively [ Time Frame: fourth week postoperative ]
  child's SDQ score fourth week postoperatively

Current Secondary Outcome:

• postoperative pain Level (by VAS) [ Time Frame: 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 Level (by CHEOPS) [ Time Frame: 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
• postoperative pain medication [ Time Frame: 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.
• Intraoperative awareness [ Time Frame: in the first and second postoperative day ]
  In order to record an intraoperative awareness, a semistructured interview is conducted with test questions.
• postoperative Nausea and vomiting [ Time Frame: in the first and second postoperative day ]
  Nausea and Vomiting are recognized in frequency and time using a questionnaire.

Original Secondary Outcome: Same as current

Information By: University Children's Hospital, Zurich

Dates:
Date Received: October 13, 2016
Date Started: January 2017
Date Completion: January 2019
Last Updated: October 28, 2016
Last Verified: October 2016