Clinical trial NCT02945072: Clinical Study of Behavior Problems in Children After Different Anesthesia Methods
Official title: Postoperative Behavior in Children: A Comparison of Inhalation Anesthesia (Sevoflurane) Versus Total Intravenous Anesthesia (TIVA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Child Behavior
Problem Behavior
Keywords: Child Behavior
Problem Behavior
postoperative behaviour problems
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
timeFrame: first week postoperative
measure: Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
timeFrame: second week postoperative
measure: Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
timeFrame: fourth week postoperative
measure: SDQ Questionnaire score postoperatively
timeFrame: first week postoperative
measure: SDQ Questionnaire score postoperatively
timeFrame: second week postoperative
measure: SDQ Questionnaire score postoperatively
timeFrame: fourth week postoperative
Secondary outcomes:
measure: postoperative pain Level (by VAS)
timeFrame: in the first postoperative week (3 times a day)
measure: postoperative pain Level (by CHEOPS)
timeFrame: in the first postoperative week (3 times a day)
measure: postoperative pain medication
timeFrame: in the first postoperative week
measure: Intraoperative awareness
timeFrame: in the first and second postoperative day
measure: postoperative Nausea and vomiting
timeFrame: in the first and second postoperative day
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Dr. Philipp Buehler
Study officials:
affiliation: University children hosptial Zurich
name: Philipp Buehler, MD
role: STUDY_CHAIR
References: